SYMBIOS® OSNRM1224

GUDID EFRIOSNRM12241

OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)

Dentsply Implants Manufacturing GmbH

Pliable-polymer dental regeneration membrane, bioabsorbable, ligated

• Primary Device ID: EFRIOSNRM12241
• NIH Device Record Key: 4ba70b11-8437-4bcd-a7c5-8c795607b675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYMBIOS®
• Version Model Number: USOSNRM1224
• Catalog Number: OSNRM1224
• Company DUNS: 344038836
• Company Name: Dentsply Implants Manufacturing GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFRIOSNRM12240 [Primary]
HIBCC	EFRIOSNRM12241 [Package]; Contains: EFRIOSNRM12240; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964342

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-03

On-Brand Devices [SYMBIOS®]

• EFRIOSTRNRM25301: OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (25x30mm)
• EFRIOSTRNRM12201: OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (12x20mm)
• EFRIOSNRM25301: OsteoShield® PTFE Non-Resorbable Membrane (25x30mm)
• EFRIOSNRM12241: OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)
• EFRIOSCRM30401: OsteoShield® Collagen Resorbable Membrane (30x40mm)
• EFRIOSCRM20301: OsteoShield® Collagen Resorbable Membrane (20x30mm)
• EFRIOSCRM15201: OsteoShield® Collagen Resorbable Membrane (15x20mm)
• EFRI9700003042: OSTEOGRAF/N-700 (4x3.0g)
• EFRI9700001042: OSTEOGRAF/N-700 (4x1.0g)
• EFRI9400003042: OSTEOGRAF/LD-300 (4x3.0g)
• EFRI9400001042: OSTEOGRAF/LD-300 (4x1.0g)
• EFRI9400000542: OSTEOGRAF /LD-300 (4x0.5g)
• EFRI9300003042: OSTEOGRAF/N-300 (4x3.0g)
• EFRI9300001042: OSTEOGRAF/N-300 (4x1.0g)
• EFRI9200001042: OSTEOGRAF/D-300 (4x1.0g)
• EFRI9000003042: OSTEOGRAF/D-700 (4x3.0g)
• EFRI9000001042: OSTEOGRAF/D-700 (4x1.0g)
• D716OSTRNRM25301: OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (25x30mm)
• D716OSTRNRM12201: OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (12x20mm)
• D716OSNRM25301: OsteoShield® PTFE Non-Resorbable Membrane (25x30mm)
• D716OSNRM12241: OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)
• EFRI325974022: Symbios BoneShield rectangular 33x25 mm
• EFRI325974012: Symbios BoneShield triangular 21x17 mm
• EFRI325974002: Symbios BoneShield oval 20x15 mm
• 07392532233357: SinusSet
• 07392532239052: Symbios BoneShield rectangular 33x25 mm
• 07392532239045: Symbios BoneShield triangular 21x17 mm