AccessGUDID - DEVICE: AnchorKnot Tissue Approximation Kit (07540299000150)

GUDID

Device Identifier (DI) Information

Brand Name: AnchorKnot Tissue Approximation Kit
Version or Model: PSZ-400-312
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baylis Medical Technologies Inc

Primary DI Number: 07540299000150
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 240389677 *Terms of Use
Previous DI: 00685447001768

Device Description: AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2-0)

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:	Yes
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?
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a149887-f624-4490-a632-146027ff0d9c
Public Version Date: April 16, 2024
Public Version Number: 2
DI Record Publish Date: November 16, 2022