PERFORM™ HUMERAL SYSTEM
GUDID 00846832078943
TORNIER, INC.
Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00846832078943 |
| NIH Device Record Key | 4c8fe052-7999-43f1-8736-0856dc5d137e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERFORM™ HUMERAL SYSTEM |
| Version Model Number | MWX3PL |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832078943 [Primary] |
FDA Product Code
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
[00846832078943]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2020-11-12 |
On-Brand Devices [PERFORM™ HUMERAL SYSTEM]
Trademark Results [PERFORM]
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