Catalog Number

P44-130-5515-SK

Brand Name

Grappler™ Suture Anchor System

Version/Model Number

P44-130-5515-SK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

MBI

Product Code Name

Fastener, fixation, nondegradable, soft tissue

Public Device Record Key

a0d6a7d2-ba7e-4768-8999-53c68f3a185c

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-