| Primary Device ID | 00810021864358 |
| NIH Device Record Key | 2b9d7ca8-42c5-4ebc-a2bd-85f00bc095f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SubChon |
| Version Model Number | M08 N0002 |
| Catalog Number | M08 N0002 |
| Company DUNS | 079700711 |
| Company Name | In2Bones USA, LLC |
| 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 |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021864358 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
[00810021864358]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-04 |
| Device Publish Date | 2024-12-10 |
| 00810021864259 | SubChon Implant Sizer, NS |
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| 00810021869711 | Instrument Kit,Size 9 mm,Back Load Single-Use,Sterile |
| 00810021869704 | Instrument Kit,Size 7 mm,Back Load Single-Use,Sterile |
| 00810021869698 | Instrument Kit,Size 5 mm,Back Load Single-Use,Sterile |
| 00810021866819 | SubChon Instrument Kit, Size 11mm, Single-Use, Sterile |
| 00810021866802 | SubChon Instrument Kit, Size 9mm, Single-Use, Sterile |
| 00810021866796 | SubChon Instrument Kit, Size 7mm, Single-Use, Sterile |
| 00810021866789 | SubChon Instrument Kit, Size 5mm, Single-Use, Sterile |
| 00810021866765 | SubChon Sizing Kit, Single-Use, Sterile |
| 00810021866758 | SubChon Instrument Kit, Size 11mm, Single-Use, Sterile |
| 00810021866741 | SubChon Instrument Kit, Size 9mm, Single-Use, Sterile |
| 00810021866734 | SubChon Instrument Kit, Size 7mm, Single-Use, Sterile |
| 00810021866727 | SubChon Instrument Kit, Size 5mm, Single-Use, Sterile |
| 00810021864358 | SubChon System Reusable Instrument Tray |