ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950021871
• Version / Model: 0531009
• Catalog Number: 0531009
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-19
• Public Version: 1
• Public Version Date: 2019-10-28
• Public Version Status: New
• Public Device Record Key: 6641c43f-0b3c-47d1-8570-b962d68c8da3

Device Description

BOWL SPONGE 1QT STAINLESS STEEL 5-3/4"X2-1/2"

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: Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	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	00614950021871	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	2.5	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required