Design Options® - ST. LUKES - NERVE BLOCK - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: ST. LUKES - NERVE BLOCK

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More Product Details

Catalog Number

570324

Brand Name

Design Options®

Version/Model Number

570324

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"

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

OGJ

Product Code Name

Nerve block tray

Device Record Status

Public Device Record Key

8dd81a6f-0e7e-4d15-96f7-b0a1dfdbf87f

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

April 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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