HUMERIS 400-1103
GUDID 03701037301715
3-4 PEGS GLENOID PE CEMENTED SIZE M
FX SOLUTIONS
Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated| Primary Device ID | 03701037301715 |
| NIH Device Record Key | 5687f5b5-7f08-45e3-a7e4-a80ee72bc806 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HUMERIS |
| Version Model Number | 3-4 PEGS GLENOID PE CEMENTED SIZE M |
| Catalog Number | 400-1103 |
| 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 | true |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037301715 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163669
FDA Product Code
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2017-05-22 |
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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