Catalog Number

GCS-6920

Brand Name

Spectrum, Inc.

Version/Model Number

982-03955-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K934630,K934630,K934630

Product Code

LPZ

Product Code Name

Container, frozen donor tissue storage

Public Device Record Key

797e79f8-556a-45cc-8b6a-3cfa6a157c80

Public Version Date

February 06, 2020

Public Version Number

5

DI Record Publish Date

July 21, 2017

Package DI Number

10855495007365

Quantity per Package

25

Contains DI Package

00855495007368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box