| Primary Device ID | 08033390282772 |
| NIH Device Record Key | 0dfb68c8-e20f-4880-a0a9-6b32e244c9e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProMade Shoulder |
| Version Model Number | 9CCA.13.024 |
| Catalog Number | 9CCA.13.024 |
| 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 | 08033390282772 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
[08033390282772]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-14 |
| 08033390254878 | PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm ECC. |
| 08033390254861 | PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm ECC. |
| 08033390254854 | PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm ECC. |
| 08033390254847 | PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm |
| 08033390254823 | PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm |
| 08033390254793 | PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm |
| 08033390282659 | ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm |
| 08033390282642 | ProMade Shoulder - Long Helix Drill Dia. 3,5 mm |
| 08033390282789 | ProMade Shoulder - Trial Glenosphere Dia. 40 mm |
| 08033390282772 | ProMade Shoulder - Trial Glenosphere Dia. 36 mm |
| 08033390282765 | ProMade Shoulder - Trial Eccentric Glenosphere Dia. 40 mm |
| 08033390278263 | ProMade Shoulder - Trial Eccentric Glenosphere Dia. 36 mm |