Atlanta Healthcare Services OcuDrape®

Basic Information

• Brand Name: Atlanta Healthcare Services OcuDrape®
• Primary DI: 10851736007293
• Version / Model: 10851736007293
• Catalog Number: DRA1041A
• Company Name: ATLANTA HEALTHCARE SERVICES, INC.
• Labeler DUNS: 130599421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-08-31
• Public Version Status: Update
• Public Device Record Key: d9d6fc3f-c5df-4adc-bb72-880676ab41be

Device Description

Ophthalmic Drape, Sterile, Aperture, Fluid Pouch with PVA Drain Wick, Mid-size Embossed Plastic

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: No
• 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: Yes
• Sterilization Methods: ["Ethylene Oxide", "Radiation Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMT	Drape, patient, ophthalmic	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46697	Ophthalmic surgical drape	A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10851736007293	GS1
Unit of Use	00851736007296	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K854613	000

Device Sizes

Type	Value	Unit	Text
Width	40	Inch
Length	48	Inch