AccessGUDID - DEVICE: Key Surgical Suture Booties (00849771002666)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Suture Booties
Version or Model: VB-1105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VB1105
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771002666
Issuing Agency: GS1
Commercial Distribution End Date: March 21, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Suture Booties, White, Sterile, 5 pair/pad; 5 pads per box

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
35257	Vascular booties	A sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed of radiopaque silicone materials. It is available in various sizes and may be straight or curved. The pair of devices may also be known as "jaw covers" (shods). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1 Inch

Device Record Status

Public Device Record Key: 1fda45f8-85eb-4aae-9c20-b17ddf752dbb
Public Version Date: March 25, 2024
Public Version Number: 4
DI Record Publish Date: December 09, 2020