Duns Number:008124539
Device Description: Sensi-Wrap, Self Adherent 6"x5yds Stretched, White
Catalog Number
-
Brand Name
Sensi-Wrap, Self Adherent
Version/Model Number
3285
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
fc7e29f2-f2d7-4dbc-b088-ec9d93e42895
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
Package DI Number
00616784328522
Quantity per Package
12
Contains DI Package
00616784328515
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |