MONOPOLY VC MP0220-6550

GUDID 04047844006184

The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).

SIGNUS Medizintechnik GmbH

Bone-screw internal spinal fixation system, non-sterile Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID04047844006184
NIH Device Record Keyaafc4e71-8390-4abd-a601-84d897a4b83f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMONOPOLY VC
Version Model NumberPedicle screw, cannulated, polyaxial
Catalog NumberMP0220-6550
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844006184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

[04047844006184]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-11-27
Device Publish Date2014-08-31

On-Brand Devices [MONOPOLY VC]

04047844006306The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006290The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006283The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006276The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006269The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006252The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006245The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006238The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006221The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006214The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006207The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006191The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006184The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006177The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006160The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006153The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006146The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006139The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006122The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006115The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006108The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006092The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006085The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006078The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006061The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006054The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006047The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006030The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006023The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
04047844006016The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
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