Duns Number:606417780
Device Description: 220-0103, Purple ID Tag, 1.6 16STP DL
Catalog Number
220-0643-54
Brand Name
OsteoMed
Version/Model Number
220-0643-54
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
-
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
-
Product Code
MQN
Product Code Name
EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Public Device Record Key
a81387a6-0f48-4b4f-8988-4c040c067c3d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 22, 2016
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 | 95 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7762 |
| U | Unclassified | 105 |