Duns Number:021675699
Device Description: Tunneling Tool, 12"
Catalog Number
1112
Brand Name
NA
Version/Model Number
1112
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
-
Product Code
LGW
Product Code Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Public Device Record Key
1d2277e7-138f-49e5-b2e5-e59509a8c358
Public Version Date
February 10, 2022
Public Version Number
3
DI Record Publish Date
November 12, 2014
Package DI Number
15414734400104
Quantity per Package
5
Contains DI Package
05414734400107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
3 | A medical device with high risk that requires premarket approval | 40 |