Catalog Number

7912

Brand Name

InterDry

Version/Model Number

7912

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110715,K110715,K110715

Product Code

FRL

Product Code Name

FIBER, MEDICAL, ABSORBENT

Public Device Record Key

141ddd63-f47c-48c5-9bab-14313f1c73cb

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 09, 2021

Package DI Number

00311701069426

Quantity per Package

3

Contains DI Package

00311701069358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box