AccessGUDID - DEVICE: CUFFLINK Y-KNOT CROSSFT (10845854045213)

GUDID

Device Identifier (DI) Information

Brand Name: CUFFLINK Y-KNOT CROSSFT
Version or Model: CFK-YT55K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CFK-YT55K
Company Name: Conmed Corporation

Primary DI Number: 10845854045213
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 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 5.5MM CROSSFT KNOTLESS

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?
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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 [?]
K171725	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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5.5 MM

Device Record Status

Public Device Record Key: 7db716b4-8a62-4565-b437-2306f014a836
Public Version Date: June 17, 2022
Public Version Number: 7
DI Record Publish Date: November 30, 2017