AccessGUDID - DEVICE: Versipass Suture Passer (00860794002662)

GUDID

Device Identifier (DI) Information

Brand Name: Versipass Suture Passer
Version or Model: 4726
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lincotek Medical LLC

Primary DI Number: 00860794002662
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117021487 *Terms of Use

Device Description: The VersiPass Suture Passer instrument is a reusable manual surgical instrument used to pass sutures for arthroscopic and open repair of soft tissues.

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:	No
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?
37839	Suturing unit, reusable	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	Accessories, Arthroscopic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: be9cfc13-9eb6-4dd6-b899-5877d2595cfb
Public Version Date: December 20, 2023
Public Version Number: 1
DI Record Publish Date: December 12, 2023