Sani-Tube™ Nylon Sterilization Tubing, without process indicators - Nylon Sterilization Tubing,3 in (7.6cm) x 100 ft - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Nylon Sterilization Tubing,3 in (7.6cm) x 100 ft (30.5M) per roll

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More Product Details

Catalog Number

-

Brand Name

Sani-Tube™ Nylon Sterilization Tubing, without process indicators

Version/Model Number

SN3

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

6b613ea2-d9de-43fe-b3bb-00941bbffb1a

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Additional Identifiers

Package DI Number

50732224110238

Quantity per Package

12

Contains DI Package

10732224110230

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