GUIDOR

Basic Information

• Brand Name: GUIDOR
• Primary DI: 00070942000048
• Version / Model: 5081
• Catalog Number: P6
• Company Name: SUNSTAR AMERICAS, INC.
• Labeler DUNS: 025066358
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-14
• Public Version: 6
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: a4a0d726-8ed7-4520-bb11-add5bdaebf13
• Distribution End Date: 2021-05-17

Device Description

GUIDOR® Bioresorbable Matrix Barrier

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NPK	Barrier, Synthetic, Intraoral	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58502	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00070942000048	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	28	Millimeter
Width	20	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Allow GUIDOR Matrix Barrier to reach room temperature prior to use