ProMade 9CC0.13.03D
GUDID 08033390237413
M6 Handle with Flange
LIMACORPORATE SPA
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 08033390237413 |
| NIH Device Record Key | 8254e5c9-e23a-4009-a8ae-539b5d2beccd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProMade |
| Version Model Number | 9CC0.13.03D |
| Catalog Number | 9CC0.13.03D |
| Company DUNS | 432066322 |
| Company Name | LIMACORPORATE SPA |
| 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 | 08033390237413 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112158
FDA Product Code
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
[08033390237413]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-29 |
| Device Publish Date | 2022-09-21 |
On-Brand Devices [ProMade]
| 08033390132664 | Long Stem for Glenosphere Extractor |
| 08033390116657 | Cannulated Handle with Flange |
| 08033390237338 | Glenoid Drilling Guide - Dia. 3.2 mm Drill |
| 08033390237420 | M8 Long Handle |
| 08033390237413 | M6 Handle with Flange |
| 08033390237406 | M8 Handle with Flange |
| 08033390244640 | Glenoid Drilling Guide Dia. 2,7 mm |
| 08033390271318 | ProMade - PRIMA TT Glenoid Glenosphere Positioner |
Trademark Results [ProMade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROMADE 88847850 not registered Live/Pending |
LIMACORPORATE S.P.A. 2020-03-25 |
 PROMADE 79141518 4562039 Live/Registered |
TIANJIN PROMADE SPORTS MACHINE CO., LTD. 2013-11-28 |
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