Duns Number:014578892
Device Description: Hydrocolloid Gel Blister Cushions, all one size, 1.65 IN x 2.67 IN (42 mm x 68 mm)
Catalog Number
00371678
Brand Name
RITE AID PHARMACY
Version/Model Number
011822037341
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2020
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
51d0cf0d-f1a0-4d35-bf72-146baf1e510d
Public Version Date
August 03, 2022
Public Version Number
5
DI Record Publish Date
July 31, 2019
Package DI Number
10011822037348
Quantity per Package
24
Contains DI Package
00011822037341
Package Discontinue Date
October 14, 2020
Package Status
Not 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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |