Omnifix™ - 5 mL LL 21 Ga. x 1 in. - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: 5 mL LL 21 Ga. x 1 in.

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More Product Details

Catalog Number

4610522-02

Brand Name

Omnifix™

Version/Model Number

4610522-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 04, 2020

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"

Yes

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 Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

04330fb2-04d9-45a5-b10d-9d7c370bac8c

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

04046963442309

Quantity per Package

9

Contains DI Package

04046963441999

Package Discontinue Date

April 04, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton

"B. BRAUN MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 277
U Unclassified 2