Design Options® - SESK COMBINED SPINAL & EPIDURAL TRAY 3 - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: SESK COMBINED SPINAL & EPIDURAL TRAY 3

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More Product Details

Catalog Number

530186

Brand Name

Design Options®

Version/Model Number

530186

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

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

c63145de-72bb-4674-a17c-ce8ef5a72f93

Public Version Date

May 04, 2020

Public Version Number

1

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