Design Options® - Combined Spinal/Epidural Tray - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: Combined Spinal/Epidural Tray

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More Product Details

Catalog Number

530017

Brand Name

Design Options®

Version/Model Number

530017

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

OFT

Product Code Name

Spinal epidural anesthesia kit

Device Record Status

Public Device Record Key

8ea70429-c22c-4bd6-8a56-51f5f843197e

Public Version Date

June 15, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

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