Catalog Number

BMTX-1047

Brand Name

Integra®

Version/Model Number

BMTX-1047

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K960248,K960248,K960248

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

c5d625e0-c212-496e-bea1-f03653117bb7

Public Version Date

July 23, 2018

Public Version Number

1

DI Record Publish Date

June 20, 2018

Package DI Number

30381780432061

Quantity per Package

10

Contains DI Package

10381780432067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case