Catalog Number

339117

Brand Name

Combined Spinal & Epidural

Version/Model Number

339117

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

-

Product Code

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

08addcb4-8b09-49a8-9f42-d278ace0f46e

Public Version Date

June 16, 2020

Public Version Number

5

DI Record Publish Date

November 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-