AccessGUDID - DEVICE: ConMed (10845854046098)

GUDID

Device Identifier (DI) Information

Brand Name: ConMed
Version or Model: CFKB-YT55K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CFKB-YT55K
Company Name: Conmed Corporation

Primary DI Number: 10845854046098
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: CuffLink Implant System with Y-Knot RC Tape and 5.5 mm CrossFT Knotless Biocomposite

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:	Yes
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?
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MBI	Fastener, fixation, nondegradable, soft tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180763	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY
Storage Environment Temperature: less than 40 Degrees Celsius
Storage Environment Temperature: less than 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.5mm + YRC TAPE

Device Record Status

Public Device Record Key: d675ef88-0a96-4149-a93f-7957a1daccec
Public Version Date: June 07, 2022
Public Version Number: 2
DI Record Publish Date: August 17, 2018