| Primary Device ID | 04546540391803 |
| NIH Device Record Key | 7bd6b1d0-07f2-44c5-946d-ad35745ce420 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5100015252 |
| Catalog Number | 5100-015-252 |
| 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 Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540391803 [Primary] |
| EIA | UNIT, OPERATIVE DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
Moist Heat or Steam Sterilization
[04546540391803]
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 |
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| 07613327262889 - XIA II | 2025-03-10 ROD ROTATION FORCEPS |
| 07613327263169 - XIA II | 2025-03-10 POLYAXIAL SCREWDRIVER, XIA 3 STYLE |
| 07613327263237 - XIA II | 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER XIA 3 STYLE |
| 07613327266887 - MANTIS | 2025-03-10 TORQUE WRENCH |
| 07613327267044 - MANTIS Redux | 2025-03-10 SHAFT FOR POLYAXIAL SCREWDRIVER |
| 07613327267785 - AVS | 2025-03-10 AL SPACER IMPACTOR STRAIGHT |