Duns Number:109903521
Device Description: MAGNUMWIRE SURGICAL SCISSOR PKG
Catalog Number
OM-9046
Brand Name
MAGNUMWIRE
Version/Model Number
OM-9046
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
-
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
HRR
Product Code Name
SCISSORS, ORTHOPEDIC, SURGICAL
Public Device Record Key
a051e06e-62ff-4a0b-8292-e4fd351eef12
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
October 08, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |