Catalog Number

508-328

Brand Name

BARR-SHUFORD RECTAL SPECULUM

Version/Model Number

508-328

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"

-

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

FFQ

Product Code Name

SPECULUM, RECTAL

Public Device Record Key

dac1af47-60cb-4c73-9497-a7f569602f94

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-