Catalog Number

17-HAP24

Brand Name

Batrik First Check Scope Bag 24"

Version/Model Number

17-HAP24

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

cdb1ece0-8a31-4f36-9c4c-2c62224197b8

Public Version Date

December 14, 2021

Public Version Number

1

DI Record Publish Date

December 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-