ColorTrack® Roll Tape - Intended to help identify surgical instruments - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Intended to help identify surgical instruments through processing and use

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ColorTrack® Roll Tape

Version/Model Number

151009SPEC

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

1f6aace5-214a-4698-846a-8c08f84a8307

Public Version Date

April 07, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

00840113224609

Quantity per Package

25

Contains DI Package

00840113224593

Package Discontinue Date

February 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"ASPEN SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 952
2 A medical device with a moderate to high risk that requires special controls. 494