Duns Number:187502109
Device Description: TRAY BASE FOR CROSS-SCREW INSTRUMENTATION SET
Catalog Number
234-500-201
Brand Name
Cross-Screw
Version/Model Number
234-500-201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2018
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
9abcbf9c-77c5-450e-b96a-c66faf6cef10
Public Version Date
July 08, 2021
Public Version Number
7
DI Record Publish Date
September 04, 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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |