SUCTION HANDLE

Basic Information

• Brand Name: SUCTION HANDLE
• Primary DI: 00841494104801
• Version / Model: H78B
• Catalog Number: H78B
• Company Name: Cynosure, LLC
• Labeler DUNS: 780318028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2023-01-11
• Public Version Status: Update
• Public Device Record Key: f323d6a9-ac94-4e8c-ab34-6d9bc0b58118

Device Description

SUCTION HANDLE(25PCS)FOR CORNEAL SHIELDS

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17652	Epithelial-resurfacing corneal shield	A mechanical eye shield made of an animal-derived biodegradable material (e.g., collagen) intended to be placed on the eye to protect the cornea and permit clinical observation and partial patient vision during postsurgical epithelial resurfacing of the cornea. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841494104801	GS1
Unit of Use	00841494106683	GS1