Duns Number:044606982
Device Description: Proximate skin Staplers (35 Regular) Contains 35 Stainless Steel Staples (Fixed Head)
Catalog Number
PXR35
Brand Name
Proximate
Version/Model Number
PXR35
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
2587f04b-67fb-41ee-9671-176196e62add
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
30705036002660
Quantity per Package
36
Contains DI Package
10705036002666
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |