AccessGUDID - DEVICE: CONMED (10845854024461)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 25.50014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25.50014
Company Name: Conmed Corporation

Primary DI Number: 10845854024461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: LIBERATOR KNIFE, 4.5 MM X 150 MM

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	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32850	Orthopaedic knife	A hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes and sizes, with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTS	KNIFE, ORTHOPEDIC

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 150 Millimeter
Width: 4.5 Millimeter

Device Record Status

Public Device Record Key: 482debb7-bb58-4812-bdaf-f52e08ba0bde
Public Version Date: July 30, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

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

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: 20845854024468
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(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES