Duns Number:830016148
Device Description: 3M™ Precise™ Disposable Skin Staple Remover, Tweezer-Style SR-1
Catalog Number
SR-1
Brand Name
3M™ Precise™
Version/Model Number
SR-1
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
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
cc9733e8-69e5-444c-b7b2-da414147a71c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50707387030204
Quantity per Package
3
Contains DI Package
30707387030200
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |