| Primary Device ID | 04546540501615 |
| NIH Device Record Key | fa0df900-88d0-40a1-8ee8-009c291ecff6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AO |
| Version Model Number | 6203110000 |
| Catalog Number | 6203110000 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540501615 [Primary] |
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04546540501615]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 07613327115123 | Right Angle Drive - Large Reamer |
| 07613154055180 | Large Reamer |
| 04546540501707 | Large Reamer |
| 04546540501615 | Small Drill |
| 04546540216472 | 3.25:1 Large Reamer |
| 04546540216403 | 1:1 Small Drill |
| 04546540068217 | Large Reamer |
| 04546540068156 | Small Drill |