676 - 4/Eye Pads & 4/Tape - 8/Unit

Basic Information

• Brand Name: 676 - 4/Eye Pads & 4/Tape - 8/Unit
• Primary DI: 00766588140087
• Version / Model: R214-008
• Catalog Number: R214-008
• Company Name: Certified Safety Manufacturing, Inc.
• Labeler DUNS: 788460483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-27
• Public Version: 1
• Public Version Date: 2023-02-06
• Public Version Status: New
• Public Device Record Key: fc73280d-7655-4826-9ebe-1a07e7663254

Device Description

676 - 4/Eye Pads & 4/Tape - 8/Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMP	PAD, EYE	General, Plastic Surgery	878.4440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11661	Eye pad	A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766588140087	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K940333	000