RPS 8808-000-000

GUDID 07613327628357

SAW ONE

STRYKER CORPORATION

Robotic surgical navigation system

Primary Device ID	07613327628357
NIH Device Record Key	a7a5e8cc-fb94-412a-845d-e47a13f12397
Commercial Distribution Status	In Commercial Distribution
Brand Name	RPS
Version Model Number	8808000000
Catalog Number	8808-000-000
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	false
Serial Number	true
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

Customer Support Contacts

Phone	+0018002533210
Email	inst.Stryker.cs@Stryker.com
Phone	+0018002533210
Email	inst.Stryker.cs@Stryker.com
Phone	+0018002533210
Email	inst.Stryker.cs@Stryker.com
Phone	+0018002533210
Email	inst.Stryker.cs@Stryker.com
Phone	+0018002533210
Email	inst.Stryker.cs@Stryker.com

Operating and Storage Conditions

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling 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
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling 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
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling 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
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling 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
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327628357 [Primary]

FDA Product Code

OLO	Orthopedic stereotaxic instrument