SOFT CELL® PVA Foam Surgical Spears

Basic Information

• Brand Name: SOFT CELL® PVA Foam Surgical Spears
• Primary DI: 10845819000165
• Version / Model: 0525, 0525-A
• Catalog Number: 0525
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-01-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ca265c9f-fe0c-4d94-a2cf-465062bcaece

Device Description

SOFT CELL® PVA Foam Surgical Spears

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOZ	Sponge, Ophthalmic	Ophthalmic	886.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13704	Ophthalmic sponge	A device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20845819000162	GS1	Carton	15	In Commercial Distribution
Primary	10845819000165	GS1
Unit of Use	00845819000168	GS1
Package	30845819000169	GS1	Carton	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082460	000

Device Sizes

Type	Value	Unit	Text
Pore Size	250	Micrometer