Catalog Number

SP2-5211

Brand Name

Top Quality Manufacturing, Inc.

Version/Model Number

See Through Self Sealing w/ In-Built Indicator

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"

-

For Single-Use

Yes

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

397e8708-aca7-4b35-90a1-60a25e43f269

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

October 26, 2016

Package DI Number

TQ26SP252115

Quantity per Package

12

Contains DI Package

TQ26SP252111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton