Catalog Number

-

Brand Name

Salvacel

Version/Model Number

SVC2500

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMQ

Product Code Name

Restraint, protective

Public Device Record Key

95da3e8f-b5ef-4c2a-b4dc-11c0627e3fde

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Package DI Number

08436035354061

Quantity per Package

12

Contains DI Package

08436035354054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-