ColorTrack® STRIPED Identification Sheet 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

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More Product Details

Catalog Number

-

Brand Name

ColorTrack® STRIPED Identification Sheet Tape

Version/Model Number

154009BNS

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

242423c5-67cd-4ce9-8b96-c44efe07055e

Public Version Date

June 15, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

00840113229857

Quantity per Package

50

Contains DI Package

00840113229840

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