Omni-Fit FH3104
GUDID 05051693303638
Modular Femoral Head XXLN (Cobalt Chrome) 32mm Dia ( -10)
IMPLANTS INTERNATIONAL LTD
Metallic femoral head prosthesis| Primary Device ID | 05051693303638 |
| NIH Device Record Key | 4de9fdf6-c87a-489c-8f00-05dff2236546 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omni-Fit |
| Version Model Number | Modular Femoral Head XXLN (32mm Dia.) |
| Catalog Number | FH3104 |
| Company DUNS | 346627222 |
| Company Name | IMPLANTS INTERNATIONAL LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 32 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature and Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05051693303638 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072101
FDA Product Code
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-07-31 |
On-Brand Devices [Omni-Fit]
| 00501693303522 | Modular Femoral Head MN ( Cobalt Chrome) 28mm Dia ( 0) |
| 05051693303881 | Modular Femoral Head XLN (Cobalt Chrome) 36mm Dia ( +7) |
| 05051693303874 | Modular Femoral Head LN (Cobalt Chrome) 36mm Dia ( +3.5) |
| 05051693303867 | Modular Femoral Head MN (Cobalt Chrome) 36mm Dia (0) |
| 05051693303850 | Modular Femoral Head SN (Cobalt Chrome) 36mm Dia ( -3.5) |
| 05051693303812 | Modular Femoral Head XLN (Ceramic) 36mm Dia ( +7) |
| 05051693303805 | Modular Femoral Head LN (Ceramic) 36mm Dia ( +3.5) |
| 05051693303799 | Modular Femoral Head MN (Ceramic) 36mm Dia (0) |
| 05051693303782 | Modular Femoral Head SN (Ceramic) 36mm Dia ( -3.5) |
| 05051693303775 | Modular Femoral Head XLN (Ceramic) 32mm Dia ( +7) |
| 05051693303768 | Modular Femoral Head LN (Ceramic) 32mm Dia ( +3.5) |
| 05051693303751 | Modular Femoral Head MN (Ceramic) 32mm Dia (0) |
| 05051693303744 | Modular Femoral Head SN (Ceramic) 32mm Dia ( -3.5) |
| 05051693303737 | Modular Femoral Head XLN (Ceramic) 28mm Dia ( +7) |
| 05051693303720 | Modular Femoral Head MN (Ceramic) 28mm Dia (0) |
| 05051693303713 | Modular Femoral Head LN (Ceramic) 28mm Dia ( +3.5) |
| 05051693303706 | Modular Femoral Head SN (Ceramic) 28mm Dia ( -3.5) |
| 05051693303638 | Modular Femoral Head XXLN (Cobalt Chrome) 32mm Dia ( -10) |
| 05051693303621 | Modular Femoral Head XLN (Cobalt Chrome) 32mm Dia ( +7) |
| 05051693303614 | Modular Femoral Head LN (Cobalt Chrome) 32mm Dia ( +3.5) |
| 05051693303607 | Modular Femoral Head MN (Cobalt Chrome) 32mm Dia ( 0) |
| 05051693303591 | Modular Femoral Head SN (Cobalt Chrome) 32mm Dia ( -3.5) |
| 05051693303553 | Modular Femoral Head XXLN (Cobalt Chrome) 28mm Dia ( +10.5) |
| 05051693303546 | Modular Femoral Head XLN (Cobalt Chrome) 28mm Dia ( +7) |
| 05051693303539 | Modular Femoral Head LN ( Cobalt Chrome) 28mm Dia ( +3.5) |
| 05051693303515 | Modular Femoral Head SN ( Cobalt Chrome) 28mm Dia ( -3.5) |
Trademark Results [Omni-Fit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNI-FIT 76423265 2803354 Live/Registered |
Koch-Glitsch, LP 2002-06-20 |
 OMNI-FIT 74138552 1677330 Dead/Cancelled |
OMNITRITION INTERNATIONAL, INC. 1991-02-12 |
 OMNI-FIT 73291088 1177932 Dead/Cancelled |
Glendale Optical Co., Inc. 1980-12-24 |
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