Duns Number:079749303
Device Description: Suture Concepts Lead Loop Suturing Device
Catalog Number
CAT-LLSD11
Brand Name
Lead Loop
Version/Model Number
CAT-LLSD11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
K150924
Product Code
GZB
Product Code Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Public Device Record Key
c81a08a1-84d5-4e0a-9417-57b2d227dcbf
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 20, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |