| Primary Device ID | 08033390197274 |
| NIH Device Record Key | 91168b46-fa35-4f36-b939-de9d9a1f0a4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProMade Hip |
| Version Model Number | 9CC0.95.102 |
| Catalog Number | 9CC0.95.102 |
| Company DUNS | 432066322 |
| Company Name | LIMACORPORATE SPA |
| 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 | 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 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033390197274 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
[08033390197274]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-27 |
| Device Publish Date | 2024-03-19 |
| 08033390022637 - Acetabular Cups | 2026-02-09 Liner Impactor for Heads Dia=36mm |
| 08033390023412 - SMR Shoulder | 2026-02-09 Humeral Body Impactor |
| 08033390024730 - MODULUS Femoral Stem | 2026-02-09 Manual impactor |
| 08033390025485 - Instrument Set | 2026-02-09 Impactor for Cemented Cups Dia.28mm - Acetabular Cup |
| 08033390025492 - Instrument Set | 2026-02-09 Impactor for Cemented Cups Dia.32mm - Acetabular Cup |
| 08033390025683 - SPH Cups | 2026-02-09 Liner Impactor for Dia=28mm Heads - Acetabular Cup |
| 08033390025690 - SPH Cups | 2026-02-09 Liner Impactor for Dia=32mm Heads - Acetabular Cup |
| 08033390026925 - Instrument Set | 2026-02-09 Beater for Humeral Heads - SMR Shoulder |