Signature ONE
GUDID 00887868522994
Alliance Glenoid Shoulder Guide and Bone Model Right
Orthosoft Inc
Orthopaedic prosthesis implantation instrument, single-use| Primary Device ID | 00887868522994 |
| NIH Device Record Key | 0c65a46b-f0fa-4190-b5b4-9dae28aa8036 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signature ONE |
| Version Model Number | 20-8090-008-02 |
| Company DUNS | 205670032 |
| Company Name | Orthosoft 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868522994 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212560
FDA Product Code
| QHE | Shoulder Arthroplasty Implantation System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
[00887868522994]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-28 |
| Device Publish Date | 2022-07-20 |
On-Brand Devices [Signature ONE]
| 00887868522994 | Alliance Glenoid Shoulder Guide and Bone Model Right |
| 00887868522987 | Alliance Glenoid Shoulder Guide and Bone Model Left |
Trademark Results [Signature ONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIGNATURE ONE 76238512 2633118 Dead/Cancelled |
ADVANCE WATCH CO., LTD. 2001-04-10 |
 SIGNATURE ONE 73755868 1536294 Dead/Cancelled |
MESA DIAGNOSTICS, INC. 1988-05-04 |
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