| Primary Device ID | 04546540380272 |
| NIH Device Record Key | 7ea1902c-8af5-4caa-9b0f-eb8b914ddd67 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5100015250 |
| Catalog Number | 5100-015-250 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| 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 | 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 | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com | |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540380272 [Primary] |
| EIA | UNIT, OPERATIVE DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
[04546540380272]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2018-09-24 |
| 07613327601695 - Connected OR Hub | 2025-06-12 |
| 07613327601701 - SDC4K Information Management System | 2025-06-12 |
| 07613327482706 - N/A | 2025-05-08 System 9 Transfer Shield, Small |
| 07613327163278 - NA | 2025-04-28 |
| 07613327601138 - OptaBlate | 2025-04-25 Curve 10mm Probe Single Kit |
| 07613327601145 - OptaBlate | 2025-04-25 Curve 20mm Probe Single Kit |
| 07613327601152 - OptaBlate | 2025-04-25 Curve 15mm Probe Single Kit |
| 07613327631883 - OptaBlate | 2025-04-25 Straight 10MM Probe Dual Kit |