AccessGUDID - DEVICE: Key Surgical Silicone Clamp Covers (00849771014058)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Silicone Clamp Covers
Version or Model: VS-202
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771014058
Issuing Agency: GS1
Commercial Distribution End Date: January 18, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Silicone Clamp Covers, Non-Sterile, White, 0.21-inch (5.35mm) x 5-inch

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):	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?
15778	Clamp jaw cover	A device used in pairs that are placed/fitted onto the distal working end (the jaws) of a surgical instrument (e.g., vascular clamps, forceps) to improve atraumatic grip and pressure distribution when clamping an artery or a vein. It is typically a long cylindrical polymer tube available in various sizes. 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: 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: e02575eb-bd6a-4e1f-8834-b63ae858f0be
Public Version Date: January 24, 2023
Public Version Number: 5
DI Record Publish Date: December 09, 2020