Duns Number:109903521
Device Description: MAGNUM PLUS 2.8 MM KNOTLESS IMPLANT SET WITH PERFECTPAS MAGNUM PLUS 2.8 MM KNOTLESS IMPLANT SET WITH PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGE, BLUE CO-BRAID
Catalog Number
OM-9127
Brand Name
MAGNUM
Version/Model Number
OM-9127
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)
Yes
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
K042914
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
b25c1e84-f064-4a49-b0c0-525c26519ec2
Public Version Date
February 08, 2022
Public Version Number
7
DI Record Publish Date
September 21, 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 |