Duns Number:012430880
Device Description: Strip Wound Closure Opaque
Catalog Number
9004316
Brand Name
Henry Schein
Version/Model Number
9004316
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FPX
Product Code Name
Strip, adhesive, closure, skin
Public Device Record Key
1731991e-24f4-4d9d-9a22-4d9d0dde4113
Public Version Date
July 30, 2021
Public Version Number
1
DI Record Publish Date
July 22, 2021
Package DI Number
H65890043162
Quantity per Package
4
Contains DI Package
H65890043161
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |