Catalog Number

811-052

Brand Name

TEE Kit

Version/Model Number

811-052

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

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

5f00e6d7-0382-45a8-a90a-9a76340fb4aa

Public Version Date

September 06, 2021

Public Version Number

4

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-