Catalog Number

0921839SR

Brand Name

Bosworth Supergel Fresh

Version/Model Number

0921839SR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

K940402

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

84b123b8-1f26-4ba3-92e4-42c8cccd78bc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-