Snowden-Pencer

Basic Information

• Brand Name: Snowden-Pencer
• Primary DI: 10885403285356
• Version / Model: 88-1004K
• Catalog Number: 881004K
• Company Name: STERIS CORPORATION
• Labeler DUNS: 021599373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 4
• Public Version Date: 2024-08-14
• Public Version Status: Update
• Public Device Record Key: ee360859-29f1-496f-971c-bcd19ee15093

Device Description

Fiber Optic Light Panel 6 inches 15.2CM

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: No
• 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
FDG	RETRACTOR, FIBEROPTIC	Gastroenterology, Urology	876.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65349	Open surgical site internal light	An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20885403285353	GS1	Box	6	In Commercial Distribution
Primary	10885403285356	GS1

Customer Contacts

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