Catalog Number

056021

Brand Name

PROTESIL INDURENT GEL 60 ML

Version/Model Number

056021

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"

-

For Single-Use

-

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

K935892,K935892

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

684fa3e0-407f-4552-973f-c84e55696d91

Public Version Date

July 01, 2021

Public Version Number

2

DI Record Publish Date

September 06, 2019

Package DI Number

68033712561150

Quantity per Package

72

Contains DI Package

08033712561158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX