Articulating Paper - Articulating Paper, XX Thin, Blue 0.00125"/32 µm - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Articulating Paper, XX Thin, Blue 0.00125"/32 µm

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More Product Details

Catalog Number

-

Brand Name

Articulating Paper

Version/Model Number

TPXXT

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

EFH

Product Code Name

PAPER, ARTICULATION

Device Record Status

Public Device Record Key

f743ffff-3426-4c31-89bd-fc8bce857534

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

30732224001723

Quantity per Package

12

Contains DI Package

10732224001729

Package Discontinue Date

-

Package Status

In Commercial Distribution

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