Regenx

Basic Information

• Brand Name: Regenx
• Primary DI: 00614950009503
• Version / Model: 32905291
• Catalog Number: 32905291
• 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: 2018-03-06
• Public Version: 2
• Public Version Date: 2019-05-07
• Public Version Status: Update
• Public Device Record Key: 2a6201c5-ff98-4eb5-a2fc-64c375e86916

Device Description

Symbios Socket Grafting KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	DRESSING, WOUND, COLLAGEN	Unknown		U
NPL	Barrier, animal source, intraoral	Dental	872.3930	2
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	General, Plastic Surgery	878.4493	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950009503	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	20	Millimeter
Width	15	Millimeter
Length	1	Centimeter
Width	2	Centimeter
Length	18	Millimeter