Duns Number:216344051
Device Description: Transparent dressing 15cm x 20cm, Carton of 10Transparent dressing 6in x 8in, Carton of 10
Catalog Number
-
Brand Name
OPSITE™ FLEXIGRID
Version/Model Number
4631,66024631
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)
-
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
f4e70bd3-e1f0-4333-b032-7623ae436f02
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
October 19, 2021
Package DI Number
05000223046316
Quantity per Package
10
Contains DI Package
05000223415433
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton 4631
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |