Duns Number:116995646
Device Description: 7.5mm Cannulated Screw, 20 Thread, L 135mm 316L SS
Catalog Number
1703-753-135
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
T 700
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
K113084
Product Code
HTN
Product Code Name
Washer, Bolt Nut
Public Device Record Key
86ec89ac-1720-41dd-9a53-3bef1227a0d4
Public Version Date
July 24, 2019
Public Version Number
5
DI Record Publish Date
October 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 | 2246 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3237 |