RPM™ Reinforced PTFE Mesh

GUDID D765RPM200XLK0

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

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Primary Device IDD765RPM200XLK0
NIH Device Record Key7b4f4259-17b1-464a-81c6-ad47068109dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPM™ Reinforced PTFE Mesh
Version Model NumberRPM200XLK
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765RPM200XLK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPKBarrier, Synthetic, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [RPM™ Reinforced PTFE Mesh]

DR65RPM250XLM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200XLKM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200XLK0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200XL0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PTCM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PTC0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PST0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PS0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PLT0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PL0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PDMR0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PDML0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200PD0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200K20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200BL0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200ATCM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200ATC0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM200BLL0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250XLKM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250XLKM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PTCM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PTCM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PSTM30RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PSM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PLTM30RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PLM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PDMR0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PDML0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250PDM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250K2M20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250BLM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250ATCM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250ATCM0RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for
D765RPM250XLM20RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for

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