ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950025503
• Version / Model: 0032936
• Catalog Number: 0032936
• 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: 2019-10-24
• Public Version: 1
• Public Version Date: 2019-11-01
• Public Version Status: New
• Public Device Record Key: cfa4288c-20c4-4c00-9dca-592132f369b0

Device Description

PROTRACTOR CEPHALOMETRIC L/F *COLD STERILIZE ONLY*

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTH	PROTRACTOR	Orthopedic	888.4600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37529	Bone-angle protractor	A device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950025503	GS1

Customer Contacts

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

Storage Conditions

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