Crosstex International - (3.5X9 SURE.CHECK-500/BX) - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: (3.5X9 SURE.CHECK-500/BX)

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More Product Details

Catalog Number

SCS25

Brand Name

Crosstex International

Version/Model Number

SCS25

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

742c6692-a013-4508-ab76-f9cc62b7357c

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

November 11, 2016

Additional Identifiers

Package DI Number

50732224109676

Quantity per Package

10

Contains DI Package

10732224109678

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