Primary Device ID | 08809595975517 |
NIH Device Record Key | 18491ff6-44ad-4ea5-8025-99fb7f0eab4c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Genie RCR Instruments |
Version Model Number | BMA-4518-TAP |
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 | 08809595975517 [Primary] |
HWX | Tap, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
Moist Heat or Steam Sterilization
[08809595975517]
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) |