SPONGE BOWL

Basic Information

• Brand Name: SPONGE BOWL
• Primary DI: 00192896021648
• Version / Model: 125-618
• Catalog Number: 125-618
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-11
• Public Version: 2
• Public Version Date: 2020-10-16
• Public Version Status: Update
• Public Device Record Key: 2694264d-44c0-40e7-a36b-8a8cb9473118
• Distribution End Date: 2020-10-15

Device Description

SPONGE BOWL

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13692	Sponge bowl, reusable	A receptacle specifically designed to store and/or collect sponges; it may be used to collect sponges during a surgical procedure. It is typically made of stainless steel and can be used for multiple patients after appropriate sterilization. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896021648	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5.75	Inch
Width	2.5	Inch