Catalog Number

904900P

Brand Name

ALLthread PEEK-OPTIMA

Version/Model Number

904900P

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

K071569,K080088

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

d1f7b4bb-6947-4b20-a1da-1c555e9074a6

Public Version Date

November 03, 2020

Public Version Number

6

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-