Top Quality Manufacturing, Inc. ™ - Sterilization Pouches - See Through Self Sealing - TOP QUALITY MANUFACTURING, INC.

Duns Number:113630649

Device Description: Sterilization Pouches - See Through Self Sealing w/ Built-In Indicator, Item # SP2-2250, 2 Sterilization Pouches - See Through Self Sealing w/ Built-In Indicator, Item # SP2-2250, 200 Pouches, Single Use

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More Product Details

Catalog Number

SP2-2250

Brand Name

Top Quality Manufacturing, Inc. ™

Version/Model Number

See Through Self Sealing w/ Built-In Indicator

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

e07c7231-4272-45ee-87dd-25b2a7a1648f

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

October 26, 2016

Additional Identifiers

Package DI Number

TQ26SP222505

Quantity per Package

16

Contains DI Package

TQ26SP222501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TOP QUALITY MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26