| Primary Device ID | 08800271234287 |
| NIH Device Record Key | 14880646-a192-46f9-b471-32a680cdd3a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneGuide Twist Drill |
| Version Model Number | OGTD2215WC |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800271234287 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
[08800271234287]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-13 |
| Device Publish Date | 2025-01-03 |
| 08809917099242 | OGTD2213T |
| 08809917099228 | OGTD2211T |
| 08809917099204 | OGTD2210T |
| 08809917070227 | HOGTD2213T |
| 08809917070210 | HOGTD2211T |
| 08809917070203 | HOGTD2210T |
| 08809917099259 | OGTD2213 |
| 08809917099235 | OGTD2211 |
| 08809917099211 | OGTD2210 |
| 08809917099198 | OGTD2208 |
| 08809917099181 | OGTD2208S |
| 08809917099174 | OGTD2207 |
| 08809917099167 | OGTD2207S |
| 08809917099150 | OGTD1506W |
| 08809917099143 | OGTD1506 |
| 08800271234119 | HOGTD2218WC |
| 08800271234102 | HOGTD2215WC |
| 08800271234096 | HOGTD2211WC |
| 08800271234089 | HOGTD2211WC |
| 08800271234072 | HOGTD2210WC |
| 08800271234065 | HOGTD2208SWC |
| 08800271240592 | OGTD2208SWC |
| 08800271234294 | OGTD2218WC |
| 08800271234287 | OGTD2215WC |
| 08800271234270 | OGTD2213WC |
| 08800271234263 | OGTD2211WC |
| 08800271234256 | OGTD2210WC |