Catalog Number

88-6636

Brand Name

Snowden-Pencer

Version/Model Number

88-6636

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

GZX

Product Code Name

INSTRUMENT, MICROSURGICAL

Public Device Record Key

5aca7540-cc2d-4ff7-a2f2-e5c533e4aea7

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

July 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-