Catalog Number

607-105-440

Brand Name

PriMatrix Ag

Version/Model Number

607-105-440

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K100261

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

177151dc-5f5b-4cd1-9cd2-f6f0fedf534e

Public Version Date

October 02, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-