Duns Number:873149871
Device Description: A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURIN A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
Catalog Number
1410101
Brand Name
ORDOCK CUP, DISPOSABLE
Version/Model Number
14-101-01
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
Yes
Prescription Use (Rx)
-
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
5d74a2f6-57bf-432d-87c2-7b0225c2898d
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
January 18, 2022
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 |