Duns Number:830016148
Device Description: ACE™ Brand Sports Tape, White, Bulk Pack 909010
Catalog Number
909010
Brand Name
3M™ ACE™ Brand
Version/Model Number
909010
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
f195f67c-fd05-4021-94de-bb71bdbe3e30
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
50051131204602
Quantity per Package
6
Contains DI Package
00051131204607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 274 |
2 | A medical device with a moderate to high risk that requires special controls. | 444 |
U | Unclassified | 7 |