AccessGUDID - DEVICE: Y-Knot (20845854080549)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Knot
Version or Model: YRC02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: YRC02
Company Name: Conmed Corporation

Primary DI Number: 20845854080549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Y-Knot RC All-Suture Anchor, with two #2 ( 5 Metric) Hi-Fi Sutures (1 Blue and 1 White/Black)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133224	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
No Device Sizes

Device Record Status

Public Device Record Key: eef1bc49-6d79-4b32-ad7a-c7674ef08036
Public Version Date: April 08, 2024
Public Version Number: 6
DI Record Publish Date: October 24, 2015