Catalog Number

2077

Brand Name

Sealing Putty for hematocrit capillaries

Version/Model Number

2077

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2017

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GHY

Product Code Name

Hematocrit, Tube, Rack, Sealer, Holder

Public Device Record Key

d2a51801-981b-4a43-a23e-3f554ebafbbc

Public Version Date

February 11, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-