CONCEPT (10845854031308) - AccessGUDID - DEVICE

DEVICE: CONCEPT (10845854031308) Download: XML | JSON Print Device Record History View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: CONCEPT Version or Model: C6855 Commercial Distribution Status: In Commercial Distribution Catalog Number: C6855 Company Name: Conmed Corporation Primary DI Number: 10845854031308 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S® Number*: 071595540 *Terms of Use Device Description: CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT CLOSE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	Active	false

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FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: KEEP DRY

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Clinically Relevant Size

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Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: 65bbc7a4-a68b-4093-bde7-889433a8c229 Public Version Date: May 25, 2023 Public Version Number: 3 DI Record Publish Date: September 24, 2020 CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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Unit of Use DI

[?] Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?] Device Subject to Direct Marking (DM), but Excepted: No DM DI Different from Primary DI: Yes DM DI Number: 20845854031305 CLOSE

Production Identifier(s) in UDI

[?] Lot or Batch Number: Yes Serial Number: No Expiration Date: No Manufacturing Date: Yes Donation Identification Number: No CLOSE

Customer Contact

[?] Phone: +1(866)426-6633 Email: [email protected] CLOSE

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