| Primary Device ID | 08809986607324 |
| NIH Device Record Key | 38cf04d5-3fd9-4f64-a7a5-4c6aa9010217 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMII Implant Impression coping (Transfer type) |
| Version Model Number | MTICH40L |
| Company DUNS | 631169224 |
| Company Name | InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809986607324 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
[08809986607324]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-29 |
| Device Publish Date | 2025-04-21 |
| 08809986607270 | ATICH50L |
| 08809986607263 | ATICH50S |
| 08809986607362 | MTICH55L |
| 08809986607355 | MTICH55 |
| 08809986607348 | MTICH45L |
| 08809986607331 | MTICH45 |
| 08809986607324 | MTICH40L |
| 08809986607317 | MTICH40 |