Nylon Self-seal Sterilization Pouch - Nylon Self-seal Sterilization Pouch - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Nylon Self-seal Sterilization Pouch

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More Product Details

Catalog Number

-

Brand Name

Nylon Self-seal Sterilization Pouch

Version/Model Number

NSP-400, 405, 410, 420, 430

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

abd8ade2-3a58-4b02-aeaf-2ab10369ea9c

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CROSSTEX INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 25