Catalog Number

XX-5013

Brand Name

Dermalon

Version/Model Number

XX-5013

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

K981582,K981582

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

36326212-2791-494b-a3ad-635daf4cba2b

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 03, 2015

Package DI Number

20884521139814

Quantity per Package

36

Contains DI Package

10884521139817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE