Catalog Number

SD-100

Brand Name

Spectrum, Inc.

Version/Model Number

982-03954-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 03, 2019

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

Product Code

LPZ

Product Code Name

Container, frozen donor tissue storage

Public Device Record Key

2101c9fe-7716-4d9c-9b98-51980589b7e5

Public Version Date

February 06, 2020

Public Version Number

5

DI Record Publish Date

July 21, 2017

Package DI Number

10855495007358

Quantity per Package

5

Contains DI Package

00855495007351

Package Discontinue Date

July 03, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper