Duns Number:027680821
Device Description: Intended to help identify surgical instruments through processing and use
Catalog Number
-
Brand Name
ColorTrack® Roll Tape
Version/Model Number
151008SPEC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
fd71f3f5-8f21-4eea-8713-c9d2bf78ce62
Public Version Date
April 07, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2021
Package DI Number
00840113224623
Quantity per Package
25
Contains DI Package
00840113224616
Package Discontinue Date
February 25, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| 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 |