Duns Number:832637081
Device Description: TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/LEFT
Catalog Number
487975
Brand Name
NA
Version/Model Number
487.975
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2017
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
K981075
Product Code
MQN
Product Code Name
EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Public Device Record Key
d853dd8f-caca-4c4d-b3b8-4af66bd39225
Public Version Date
October 10, 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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |