Duns Number:435428396
Device Description: BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip intended fo BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.
Catalog Number
-
Brand Name
BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length
Version/Model Number
ASB0120
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIH
Product Code Name
Dispenser, Cement
Public Device Record Key
9e9ea92e-5c59-47a3-85b6-38ab58134cf5
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |