Duns Number:482661753
Device Description: SENTIO MMG JAMSHIDI TROCAR 6 INCH 11 GAUGE
Catalog Number
286202611T
Brand Name
SENTIO
Version/Model Number
286202611T
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
K173134
Product Code
PDQ
Product Code Name
Neurosurgical nerve locator
Public Device Record Key
c225fa14-6987-41ea-8440-8b5aad268704
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
October 08, 2018
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |