ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950016426
• Version / Model: 0034300
• Catalog Number: 0034300
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 1
• Public Version Date: 2019-10-24
• Public Version Status: New
• Public Device Record Key: ccbc4908-d616-434a-a3c8-f65b4307f9f5

Device Description

SYRINGE CVD TIP ACE 50/BX L/F NS 12CC FOR IRRG DISP 10BX/CA

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
EIC	SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950016426	GS1
Unit of Use	10614950016423	GS1

Customer Contacts

• Phone: [phone] ext. 214
• Email: [email protected]

Storage Conditions

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