Duns Number:486711679
Device Description: NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE
Catalog Number
07704105S
Brand Name
Norian
Version/Model Number
07.704.105S
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
K073303,K102722
Product Code
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
b9b7cccc-f2f4-4f13-b851-927945d8c9fe
Public Version Date
April 29, 2022
Public Version Number
5
DI Record Publish Date
September 14, 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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |