Duns Number:339583417
Device Description: SPIDER SELF- LIGATING K2 Ø 1,9x6
Catalog Number
SXL-1906
Brand Name
SPIDER SCREW
Version/Model Number
SXL-1906
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
K091390
Product Code
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
8e18c899-448d-4988-89c1-ef32d8591e79
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 24, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 29 |