AccessGUDID - DEVICE: Y-Knot (20845854901196)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Knot
Version or Model: YP1301RB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: YP1301RB
Company Name: Conmed Corporation

Primary DI Number: 20845854901196
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Y-Knot® Pro Flex 1.3 mm Anchor, Ribbon White/Blue

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 [?]
K111779	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: 1.3 mm

Device Record Status

Public Device Record Key: 299e404d-48c4-475f-aef1-1bf791785ce8
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: July 17, 2019