Duns Number:089138159
Device Description: Sterile Wound Closure Strips- 1/4"x4"
Catalog Number
84098602155
Brand Name
Premier Value
Version/Model Number
84098602155
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
K931005,K931005,K931005
Product Code
FPX
Product Code Name
Strip, Adhesive, Closure, Skin
Public Device Record Key
fbe65ab8-92b3-4f9f-a303-41b6ebac7f64
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
Package DI Number
10840986021555
Quantity per Package
24
Contains DI Package
00840986021558
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |