Duns Number:904569092
Device Description: IMPLANT STRONG SW HE Ø3,75 X 11,5MM
Catalog Number
SWHE 3711
Brand Name
Strong SW
Version/Model Number
SWHE 3711
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
K170398
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
7af04baa-6001-406c-90f5-ce304b8f07b7
Public Version Date
June 22, 2022
Public Version Number
1
DI Record Publish Date
June 14, 2022
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. | 1337 |