SOFT SHIELD® Collagen Shields

Basic Information

• Brand Name: SOFT SHIELD® Collagen Shields
• Primary DI: 00845819005781
• Version / Model: 7072
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 79ff89e3-ceea-4713-a155-bbf62bb3e080

Device Description

SOFT SHIELD® Collagen Shield, 72 Hours (CE)

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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOE	Collagen Corneal Shield	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
Package	10845819005788	GS1	Carton	10	In Commercial Distribution
Primary	00845819005781	GS1

Customer Contacts

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