Catalog Number

706925

Brand Name

Spectrum, Inc.

Version/Model Number

982-03563-000

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

K923099,K923099,K923099

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

cdd20f0d-d70f-4f95-ae27-f03ad9b1fab5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 30, 2017

Package DI Number

00850301007334

Quantity per Package

25

Contains DI Package

00850301007099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box