Duns Number:066839630
Device Description: Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as custome Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as customer orders
Catalog Number
-
Brand Name
OsteoExpress
Version/Model Number
GDNS-5215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2021
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
K151543
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
3f64e268-c0d5-4fe8-ae20-0608e7ad27bf
Public Version Date
March 02, 2021
Public Version Number
2
DI Record Publish Date
March 21, 2019
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |