Catalog Number

88-1006K

Brand Name

Snowden-Pencer

Version/Model Number

88-1006K

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

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

-

Product Code

FDG

Product Code Name

RETRACTOR, FIBEROPTIC

Public Device Record Key

59c5edd2-c225-43ee-8ceb-3368f5a4bc35

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 29, 2021

Package DI Number

20885403285377

Quantity per Package

6

Contains DI Package

10885403285370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box