RPM™ Reinforced PTFE Mesh

GUDID D765RPM200PDML0

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

Osteogenics Biomedical Inc

Dental/maxillofacial surgical mesh

• Primary Device ID: D765RPM200PDML0
• NIH Device Record Key: a15a8874-bc59-4cb2-bbd7-bfbd35a93bc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RPM™ Reinforced PTFE Mesh
• Version Model Number: RPM200PDML
• Company DUNS: 123853058
• Company Name: Osteogenics Biomedical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Length: 38 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D765RPM200PDML0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171774

FDA Product Code

• NPK: Barrier, Synthetic, Intraoral

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

On-Brand Devices [RPM™ Reinforced PTFE Mesh]

• DR65RPM250XLM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200XLKM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200XLK0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200XL0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PTCM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PTC0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PST0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PS0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PLT0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PL0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PDMR0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PDML0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200PD0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200K20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200BL0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200ATCM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200ATC0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM200BLL0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250XLKM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250XLKM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PTCM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PTCM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PSTM30: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PSM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PLTM30: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PLM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PDMR0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PDML0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250PDM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250K2M20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250BLM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250ATCM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250ATCM0: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
• D765RPM250XLM20: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for