Catalog Number

081200

Brand Name

A-GLIDE™

Version/Model Number

081200

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"

-

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

e7dd6b5e-9c8c-4ef0-88d7-37be28a64eeb

Public Version Date

February 01, 2022

Public Version Number

1

DI Record Publish Date

January 24, 2022

Package DI Number

10850012846199

Quantity per Package

6

Contains DI Package

00850012846192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case