Duns Number:791619393
Device Description: Disposable Dilator KitKit Contains:ML-0444SInsulated Dilator Set, 7, 12, & 15 MM, SterileM Disposable Dilator KitKit Contains:ML-0444SInsulated Dilator Set, 7, 12, & 15 MM, SterileML-0345Dilator Clip
Catalog Number
-
Brand Name
SeaSpine
Version/Model Number
ML-0459
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
ba8471b5-db92-4a4b-8390-051ce23919d1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 12, 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 | 2398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |