Catalog Number

-

Brand Name

GLASSCOCK OTOLOGY SURGERY DRAPE

Version/Model Number

SD-2100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

57a8d044-3bc9-4ec4-ab4b-c7bb1830d754

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2018

Package DI Number

10850000126081

Quantity per Package

6

Contains DI Package

00850000126084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-