AmerisourceBergen - Laparotomy Sponges Non-sterile pre washed 18" X - BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Duns Number:985523874

Device Description: Laparotomy Sponges Non-sterile pre washed 18" X 18"

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More Product Details

Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11207

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GDY

Product Code Name

Gauze/Sponge, Internal, X-Ray Detectable

Device Record Status

Public Device Record Key

857d8bc5-281d-445f-8019-9ffb987c291c

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Additional Identifiers

Package DI Number

60368001112071

Quantity per Package

20

Contains DI Package

00368001112079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2