Primary Device ID | 03701037320532 |
NIH Device Record Key | d5e70cdb-7fb5-44ee-8a81-f49122488b18 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Humelock II |
Version Model Number | 603-0017 |
Company DUNS | 263076196 |
Company Name | FX SOLUTIONS |
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 | false |
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 | 03701037320532 [Primary] |
HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
[03701037320532]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-11 |
Device Publish Date | 2025-03-03 |
03701037320426 - EasyTech Anatomical | 2025-03-11 MONOBLOC CUTTING GUIDE WITH GUIDE |
03701037320532 - Humelock II | 2025-03-11HUMELOCK II TRAY |
03701037320532 - Humelock II | 2025-03-11 HUMELOCK II TRAY |
03701037321010 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
03701037321027 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
03701037321034 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321041 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321058 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |
03701037321065 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HUMELOCK II 86911424 5179235 Live/Registered |
FX Solutions 2016-02-18 |