| Primary Device ID | 00889024274228 |
| NIH Device Record Key | bca6faf3-2a70-4d98-a320-01361bfc9a7a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 32-8106-00-13 |
| Catalog Number | 32-8106-000-13 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024274228 [Primary] |
| JDC | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2015-09-17 |
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