Primary Device ID | 08800298539259 |
NIH Device Record Key | 03c0a8a0-b108-4380-a92c-2221053da1c1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Surgical Instrument |
Version Model Number | 475AWL |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800298539259 [Primary] |
HWJ | Awl |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
[08800298539259]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-14 |
Device Publish Date | 2025-02-06 |
08800298539334 | 6.5mm Drill |
08800298539327 | 5.5mm Drill |
08800298539310 | 4.75 mm drill |
08800298539303 | 3.75mm Drill |
08800298539297 | 4.75 Bone Awl (Disposable) |
08800298539280 | 5.5 Bone Awl/Tap |
08800298539273 | 4.75 Bone Awl/Tap |
08800298539266 | 3.75 Bone Awl/Tap |
08800298539259 | 4.75mm Bone Awl |
08800298539242 | Guide |