Catalog Number

0921740C

Brand Name

Bosworth Sapphire

Version/Model Number

0921740C

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

-

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

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

fc27b83e-ba8c-4380-832a-b661c0b8bcc6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-