Duns Number:873149871
Device Description: PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENT PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS TO BE STERILIZED PRIOR TO USE (SEE INSTRUCTIONS FOR AUTOCLAVE)
Catalog Number
14100
Brand Name
ORDOCK PLATFORM, RE-USABLE
Version/Model Number
14-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
578d6d02-333b-458d-9b47-a45372ccb0eb
Public Version Date
February 16, 2021
Public Version Number
1
DI Record Publish Date
February 08, 2021
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |