Duns Number:486711679
Device Description: 2.4MM TI RAISED HEAD EMERG SCR PLUSDRIVE®/8MM
Catalog Number
0431584805
Brand Name
NA
Version/Model Number
04.315.848.05
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
K162594,K170818,K162594,K170818
Product Code
MQN
Product Code Name
EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Public Device Record Key
23bbdd5c-3a68-47f6-b938-f9e149ebd01f
Public Version Date
April 25, 2022
Public Version Number
2
DI Record Publish Date
December 12, 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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |