HeliMend® Advanced

Basic Information

• Brand Name: HeliMend® Advanced
• Primary DI: 10381780038535
• Version / Model: 62208
• Catalog Number: 62208
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 9
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: eb366374-a4f8-40bd-bbcd-7cd0f00a3564

Device Description

HeliMend® Advanced Absorbable Collagen Membrane

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: Yes
• 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: 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
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58740	Dental/maxillofacial soft-tissue biomatrix implant, animal-derived	A bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780038539	GS1	CAS	12	In Commercial Distribution
Primary	10381780038535	GS1
Secondary	M269622081	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992216	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			30mm x 40mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The product should be stored at room temperature. Avoid excessive heat and humidity.