HUMERIS 931-1004
GUDID 03701037312476
TRIAL GLENOID SIZE L
FX SOLUTIONS
Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 03701037312476 |
| NIH Device Record Key | f4ed77df-1af9-4540-b406-eac51ae50976 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HUMERIS |
| Version Model Number | 931-1004 |
| Catalog Number | 931-1004 |
| Company DUNS | 263076196 |
| Company Name | FX SOLUTIONS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037312476 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163669
FDA Product Code
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
[03701037312476]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-26 |
| Device Publish Date | 2019-04-18 |
On-Brand Devices [HUMERIS]
| 03701037312476 | TRIAL GLENOID SIZE L |
| 03701037312469 | TRIAL GLENOID SIZE M |
| 03701037312452 | TRIAL GLENOID SIZE S |
| 03701037312445 | TRIAL GLENOID SIZE XS |
| 03701037301722 | 3-4 PEGS GLENOID PE CEMENTED SIZE L |
| 03701037301715 | 3-4 PEGS GLENOID PE CEMENTED SIZE M |
| 03701037301708 | 3-4 PEGS GLENOID PE CEMENTED SIZE S |
| 03701037301692 | 3-4 PEGS GLENOID PE CEMENTED SIZE XS |
Trademark Results [HUMERIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HUMERIS 87622187 5537520 Live/Registered |
FX SOLUTIONS 2017-09-26 |
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