| Primary Device ID | 00889024380424 |
| NIH Device Record Key | 923e6de2-feb7-448d-b576-9f7da51d5996 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 32-8105-38 |
| 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 |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com |
| Outer Diameter | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024274082 [Primary] |
| GS1 | 00889024380424 [Package] Contains: 00889024274082 Package: [32 Units] In Commercial Distribution |
| JDB | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-08 |
| Device Publish Date | 2016-08-09 |
| 00889024660595 - BIOMET Anterior Adapter | 2024-04-23 |
| 00889024660601 - BIOMET Posterior Adapter | 2024-04-23 |
| 00889024660816 - +9MM Spacer Block C/D 10mm | 2024-04-23 |
| 00889024660823 - +9MM Spacer Block C/D 12mm | 2024-04-23 |
| 00889024660830 - +9MM Spacer Block C/D 14mm | 2024-04-23 |
| 00889024660847 - +9MM Spacer Block C/D 16mm | 2024-04-23 |
| 00889024660854 - +9MM Spacer Block C/D 18mm | 2024-04-23 |
| 00889024660861 - +9MM Spacer Block C/D 20mm | 2024-04-23 |