| Primary Device ID | 08809399748546 |
| NIH Device Record Key | 7da7939f-5857-41f4-852b-ce7f4d00c1d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genie RCR Instruments |
| Version Model Number | BHA-5320-AWL |
| Company DUNS | 688999370 |
| Company Name | OSTEONIC 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 | false |
| 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 | 08809399748546 [Primary] |
| HWJ | Awl |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
[08809399748546]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-29 |
| Device Publish Date | 2021-07-21 |
| 08809595975616 | Ø5.5 Reusable AWL |
| 08809595975609 | Ø4.5 Reusable AWL |
| 08809595975593 | Reusable Punch |
| 08809595975531 | Ø5.5 Reusable Taperad TAP |
| 08809595975517 | Ø4.5 Reusable Taperad TAP |
| 08809399748560 | Ø4.5/4.8 Reusable AWL |
| 08809399748553 | Ø4.75 Reusable Taperad TAP(Healmax) |
| 08809399748546 | Ø5.25 Reusable AWL(Healmax) |
| 08809399748539 | Ø5.25 Reusable Taperad TAP(Healmax) |