Catalog Number

OT-4601

Brand Name

OTOSILK™ Graft Dressing

Version/Model Number

OT-4601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K964534,K964534

Product Code

NAB

Product Code Name

Gauze/Sponge,Nonresorbable For External Use

Public Device Record Key

b89c3a96-f943-4c2c-9408-bc084d852d25

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

34063107102449

Quantity per Package

10

Contains DI Package

14063107102445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton