Duns Number:109903521
Device Description: INSTRUMENT TRAY FOOT AND ANKLE. TRAY ALLOWS ROOM FOR 14 INSTRUMENT TRAY FOOT AND ANKLE. TRAY ALLOWS ROOM FOR 14 MANUAL INSTRUMENTS, 10 HANDHELD INSTRUMENTS E.G. PUNCHES, GRASPERS, ETC.,
Catalog Number
72203782
Brand Name
NA
Version/Model Number
72203782
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
dea8c18d-9e9a-44b3-b7cd-0fa9728d9200
Public Version Date
September 16, 2022
Public Version Number
10
DI Record Publish Date
August 29, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |