Catalog Number

-

Brand Name

AMG

Version/Model Number

BCRW001XL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

d8ced534-f110-4207-92f6-ef2e17efe969

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 22, 2020

Package DI Number

10850017650340

Quantity per Package

10

Contains DI Package

00850017650343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case