Duns Number:131747628
Device Description: 13G OPEN TIP BMA ANGEL KIT
Catalog Number
ABS-10062K-TH13OT
Brand Name
Arthrex®
Version/Model Number
ABS-10062K-TH13OT
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
ORG
Product Code Name
Platelet and plasma separator for bone graft handling
Public Device Record Key
f6b24585-1e0f-4b72-b074-f779d6f38d1a
Public Version Date
January 21, 2022
Public Version Number
1
DI Record Publish Date
January 13, 2022
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 | 6506 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 2 |