AccessGUDID - DEVICE: Versipass Suture Passer Needle (00860794002679)

GUDID

Device Identifier (DI) Information

Brand Name: Versipass Suture Passer Needle
Version or Model: 4727
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4727
Company Name: Lincotek Medical LLC

Primary DI Number: 00860794002679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117021487 *Terms of Use

Device Description: Suture passer needle for the Versipass Suture Passer

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?
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAB	Needle, Suturing, Disposable

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 031725ef-56c9-4cfb-8431-977265534c92
Public Version Date: October 25, 2024
Public Version Number: 1
DI Record Publish Date: October 17, 2024