PhotonGuide

Basic Information

• Brand Name: PhotonGuide
• Primary DI: 00816728020080
• Version / Model: Wide / Flat
• Catalog Number: 104015
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2023-02-14
• Public Version Status: Update
• Public Device Record Key: 4c1ae832-a6df-426f-b6bb-5199773d28dd

Device Description

Illuminator, Wide/Flat

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32241	Fibreoptic operating light system	A system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816728020080	GS1
Previous	00816728020646	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius