STRAUMANN MEMBRAGEL

Basic Information

• Brand Name: STRAUMANN MEMBRAGEL
• Primary DI: 07630031700148
• Version / Model: 1
• Catalog Number: 070.101
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 6
• Public Version Date: 2023-01-17
• Public Version Status: Update
• Public Device Record Key: 34462677-ebec-4516-bf5d-cc1a9dba891d
• Distribution End Date: 2016-07-26

Device Description

Straumann® MembraGel® 0.8 ml

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: 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
NPK	Barrier, synthetic, intraoral	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42630	Hydrogel dental regeneration membrane	A sterile bioabsorbable material intended to be used to aid in dental and maxillofacial bone regeneration (e.g., after periodontal disease, or after tooth loss 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 comprised of synthetic liquid compounds that are mixed to react and form a gel (typically includes syringes and mixing tip); it is applied between soft tissue and bone during guided bone regeneration (GBR), 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
Primary	07630031700148	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082111	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.8	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight