Crosstex International - Pouch 12X18 Self Seal - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Pouch 12X18 Self Seal

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More Product Details

Catalog Number

SCL1218

Brand Name

Crosstex International

Version/Model Number

SCL1218

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)

-

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

06ae4128-0164-4f18-984c-3daf707e40e5

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

November 11, 2016

Additional Identifiers

Package DI Number

50732224109355

Quantity per Package

5

Contains DI Package

10732224109357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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