Duns Number:688731065
Device Description: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x10.0mm
Catalog Number
AIH2FR4510S
Brand Name
IH2 Fixture SLA
Version/Model Number
AIH2FR4510S
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
K153521
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
6c294d71-faa9-48d2-934d-9d17fdd5629b
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
May 31, 2019
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 185 |