StageOne™ 431406
GUDID 00887868543180
Biomet Orthopedics, LLC
Orthopaedic cement spacer mould| Primary Device ID | 00887868543180 |
| NIH Device Record Key | 432cb71c-7d2e-429c-87bd-44c5714c9e17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StageOne™ |
| Version Model Number | 431406 |
| Catalog Number | 431406 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 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 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 Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868543180 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131135
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-21 |
| Device Publish Date | 2022-09-13 |
On-Brand Devices [StageOne™]
| 00887868543302 | 433180 |
| 00887868543296 | 433175 |
| 00887868543289 | 433170 |
| 00887868543272 | 433165 |
| 00887868543265 | 432175 |
| 00887868543258 | 432170 |
| 00887868543241 | 432165 |
| 00887868543234 | 432160 |
| 00887868543227 | 431414 |
| 00887868543210 | 431412 |
| 00887868543203 | 431410 |
| 00887868543197 | 431408 |
| 00887868543180 | 431406 |
Trademark Results [StageOne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAGEONE 97373805 not registered Live/Pending |
Clean Victory, LLC 2022-04-21 |
 STAGEONE 85332053 4083371 Dead/Cancelled |
Stageone Sports 2011-05-27 |
 STAGEONE 75611920 2491157 Dead/Cancelled |
MORINAGA MILK INDUSTRY CO., LTD. 1998-12-24 |
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