| Primary Device ID | 00810009464310 |
| NIH Device Record Key | b92fc291-2e6d-407a-9a4d-68788e2e7795 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radiolucent Head Frame Case |
| Version Model Number | 07-980-00R |
| Company DUNS | 877624940 |
| Company Name | MIZUHO AMERICA, INC. |
| 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 | 00810009464310 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
[00810009464310]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-23 |
| Device Publish Date | 2023-08-15 |
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| 00810009460169 - LawtonElite Microscissors Bayonet, Reposable, Curved Left Blades, 10cm WL | 2023-08-23 Actuated Cutting |
| 00810009460541 - Yasargil Tumor Forceps, Bayonet, 5mm Serrated Spoon, 9cm WL | 2023-08-23 Actuated Holder |
| 00810009460824 - Yasargil Forceps, Bayonet, 11.5cm WL | 2023-08-23 Actuated Holder |
| 00810009461180 - Ring Curette, Donut Style, 3mm, 125 Degrees Up, 15cm WL | 2023-08-23 Static Instrument |
| 00810009462132 - Sizer Dissector, Straight | 2023-08-23 Static Instrumanet |