Duns Number:007941230
Device Description: Tray Skin Staple Remover Tweezer Style 3X3In Gauze Latex-Free Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
SSR1003
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
b7537556-da5e-4070-a46c-3c1e0a17cd3b
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2020
Package DI Number
50885632126244
Quantity per Package
48
Contains DI Package
10885632126246
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |