Duns Number:072943876
Device Description: Pain-Free Wrap, 1 roll, 2 IN x 2.3 YDS (5 cm x 2.1 m) Stretched
Catalog Number
-
Brand Name
TopCare health
Version/Model Number
036800542174
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"
Yes
For Single-Use
Yes
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
ebd65771-c82a-494d-a0e3-aaa870f9de0b
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
October 26, 2020
Package DI Number
10036800542171
Quantity per Package
72
Contains DI Package
00036800542174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |