Duns Number:320047483
Device Description: OSTYCUT® Disposable Bone Biopsy Needles, 14.5g x 50mm
Catalog Number
17860010
Brand Name
OSTYCUT®
Version/Model Number
17860010
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
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
60f1bcf1-4ef5-4b4f-8dd5-4e9cc1c1eed1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 06, 2016
Package DI Number
10801741083751
Quantity per Package
10
Contains DI Package
00801741083754
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 174 |