| Primary Device ID | 08800049425411 |
| NIH Device Record Key | 12cdd5a4-e1b7-46a4-b33f-be038aec0ee4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UF(II) Implant System |
| Version Model Number | SSCA 45505N(II) |
| Catalog Number | SSCA 45505N(II) |
| Company DUNS | 631085206 |
| Company Name | DIO Corporation |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800049425411 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
[08800049425411]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-09 |
| Device Publish Date | 2022-03-01 |