Catalog Number

-

Brand Name

Sklar®

Version/Model Number

92-2812

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092827

Product Code

HDA

Product Code Name

Forceps, obstetrical

Public Device Record Key

e27f3322-5b13-49b8-af24-f336597b65f5

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

November 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-