Batrik Safe-Soak Endo Sponge

Basic Information

• Brand Name: Batrik Safe-Soak Endo Sponge
• Primary DI: 00690521011564
• Version / Model: 17-101
• Catalog Number: 17-101
• Company Name: Batrik Medical Manufacturing Inc
• Labeler DUNS: 243880700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 0861d5a0-279a-4505-8b03-dc2460299ccd

Device Description

Tubular Sponges, Bulk

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61695	Skin-cleaning wipe, sterile	A sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690521011564	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight