Duns Number:606417780
Device Description: ExtremiLock Ankle 2.7 x 14mm Locking Screw Sterile Qty 2
Catalog Number
343-2714-SP-02
Brand Name
OsteoMed
Version/Model Number
343-2714-SP-02
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
-
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
56e0b44f-11ab-40d3-a323-5ecc26329f15
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 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 | 95 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7762 |
| U | Unclassified | 105 |