Duns Number:078293017
Device Description: SPCL,TOMCAT,UNIVERSAL JOINT DRIVER,SPLI
Catalog Number
-
Brand Name
TOMCAT™ Cervical Spinal System
Version/Model Number
SPCL-R008
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
K152515
Product Code
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
12534da4-6df9-4f65-bdc0-a4544be72c39
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
January 21, 2017
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 | 2373 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5754 |
| U | Unclassified | 61 |