Catalog Number

-

Brand Name

STERIL PEEL

Version/Model Number

221632-BL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K953829,K953829,K953829

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

4abbdea5-0475-4d62-a6e0-8cada3c18021

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

October 15, 2019

Package DI Number

D830221632BL1

Quantity per Package

250

Contains DI Package

D830221632BL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box