Catalog Number

BIP1012

Brand Name

BIOCLUSIVE® PLUS

Version/Model Number

BIP1012

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

f399d9c4-5b94-4eb9-bd72-e30042e1549b

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978006432

Quantity per Package

10

Contains DI Package

15051978006435

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-