Duns Number:062355158
Device Description: 8 Nm Torque Limiting Ratchet Wrench and 10mm Hex Bolt Socket - Non-Sterile
Catalog Number
SC-8TLR10HNS
Brand Name
Smart Correction
Version/Model Number
SC-8TLR10HNS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXC
Product Code Name
Wrench
Public Device Record Key
affedc12-b094-4bdf-8fff-7ce4a132f0b9
Public Version Date
October 03, 2022
Public Version Number
2
DI Record Publish Date
December 20, 2021
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 | 142 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1453 |