Duns Number:058311945
Device Description: EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL
Catalog Number
0937-3-215
Brand Name
INSTRUMENT
Version/Model Number
0937-3-215
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
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
9a96916f-8ee1-4cfa-ab62-3cf50730bd0d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
07613327141351
Quantity per Package
5
Contains DI Package
17613327141358
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
| 3 | A medical device with high risk that requires premarket approval | 32 |