Catalog Number

PTG-17046EB

Brand Name

NA

Version/Model Number

ES-DISP-AGR-CE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HFB

Product Code Name

Forceps, Biopsy, Gynecological

Public Device Record Key

662d109f-841a-4efc-95b4-ee3fb4fe9a8a

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Package DI Number

26950190431185

Quantity per Package

5

Contains DI Package

16950190431188

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box