Duns Number:071595540
Device Description: Reflex One, Skin Stapler, 35 regular
Catalog Number
3036R
Brand Name
REFLEX
Version/Model Number
3036R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZQ
Product Code Name
CLIP, REMOVABLE (SKIN)
Public Device Record Key
c6f01d97-5b49-4e72-9d5a-7ae1505e8fbd
Public Version Date
July 18, 2022
Public Version Number
3
DI Record Publish Date
November 13, 2020
Package DI Number
10653405050599
Quantity per Package
6
Contains DI Package
20653405050596
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |