Catalog Number

700144

Brand Name

Spectrum, Inc.

Version/Model Number

985-03503-000

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

-

Product Code

FQL

Product Code Name

STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Public Device Record Key

ca798d1f-f5a4-43dd-877d-453ae0c7f627

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2017

Package DI Number

10855495007204

Quantity per Package

20

Contains DI Package

00855495007207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper