Catalog Number

9000735-10

Brand Name

Implant Prosthetics

Version/Model Number

9000735-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2022

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Public Device Record Key

c7587b3e-2c21-49c7-b7ff-b914fe9ba862

Public Version Date

October 19, 2022

Public Version Number

3

DI Record Publish Date

June 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-