Duns Number:058311945
Device Description: SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER
Catalog Number
I-H1236HA00
Brand Name
INSTRUMENT
Version/Model Number
I-H1236HA00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
8fab2488-d269-4367-9e51-e0134da9614c
Public Version Date
January 06, 2022
Public Version Number
3
DI Record Publish Date
May 18, 2017
Package DI Number
07613327311082
Quantity per Package
25
Contains DI Package
17613327311089
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
| 3 | A medical device with high risk that requires premarket approval | 32 |