Duns Number:072943876
Device Description: Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN x 2.12 IN (34 mm x 54 mm); 0.66 IN x 2.32 IN (17 mm x 59 mm)
Catalog Number
-
Brand Name
TopCare health
Version/Model Number
036800259775
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
20464f26-2eeb-4c78-aff8-0b1cc682d1dd
Public Version Date
July 21, 2020
Public Version Number
1
DI Record Publish Date
July 13, 2020
Package DI Number
10036800259772
Quantity per Package
12
Contains DI Package
00036800259775
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 |