Catalog Number

-

Brand Name

Key Surgical Suture Booties

Version/Model Number

VB-1100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GDJ

Product Code Name

Clamp, Surgical, General & Plastic Surgery

Public Device Record Key

e0b7b901-e782-40e1-a378-758f419603aa

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2020

Package DI Number

10849771016899

Quantity per Package

5

Contains DI Package

00849771016892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box