Catalog Number

228321

Brand Name

RAPIDLOC PANACRYL

Version/Model Number

228321

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

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

K002406

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

b6b288bb-eedf-4a24-87d3-9f04ae5ef897

Public Version Date

January 28, 2021

Public Version Number

7

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-