FDA.reportPublic FDA data

External Remote Controller

Primary DI
00856719002107
Brand
External Remote Controller
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
P003
Catalog number
EAD-P1-000
Device description
External remote controller - for use with the MAGEC spinal bracing and distraction system
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGNGrowing Rod System- Magnetic Actuation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGNGrowing Rod System- Magnetic ActuationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856719002107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856719002107008567190021078567190021070856719002107

GMDN Terms#

Term, Definition table
TermDefinition
Distraction plate/rod controllerA portable, hand-held, electrically-powered device intended to be used to non-invasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail); it is not used during the implantation procedure. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-435-5477csdepartment@ellipse-tech.com
866-456-2871info@globusmedical.com

Regulatory Flags#

DUNS number
837845234
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195377108555PRECICETPT6-110-B-S2023-10-04
00195377108562PRECICETPT6-105-B-S2023-10-04
00195377108579PRECICETPT6-100-B-S2023-10-04
00195377108586PRECICETPT6-950-B-S2023-10-04
00195377108593PRECICETPT6-900-B-S2023-10-04
00195377108609PRECICETPT6-850-B-S2023-10-04
00195377108623PRECICETPT6-750-B-S2023-10-04
00195377108630PRECICETPT6-700-B-S2023-10-04
00195377108647PRECICETPT6-650-B-S2023-10-04
00195377108654PRECICETPT6-600-B-S2023-10-04
00195377108661PRECICETPT6-110-A-S2023-10-04
00195377108678PRECICETPT6-105-A-S2023-10-04
00195377108685PRECICETPT6-100-A-S2023-10-04
00195377108692PRECICETPT6-950-A-S2023-10-04
00195377108708PRECICETPT6-900-A-S2023-10-04
00195377108715PRECICETPT6-850-A-S2023-10-04
00195377108722PRECICETPT6-800-A-S2023-10-04
00195377108739PRECICETPT6-750-A-S2023-10-04
00195377108746PRECICETPT6-700-A-S2023-10-04
00195377108753PRECICETPT6-650-A-S2023-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887517834010MAGECNuvasive, Inc.PGN2017-09-09
00887517834027MAGECNuvasive, Inc.PGN2017-09-09
00887517834034MAGECNuvasive, Inc.PGN2017-09-09
00887517834041MAGECNuvasive, Inc.PGN2017-09-09
00856719002114MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002138MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002145MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002152MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002169MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002183MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002190MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002244MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022600MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022617MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022624MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022631MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022648MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022655MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022662MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022679MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022686MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022693MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022709MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022716MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258026882MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-12-23
00812258026899MAGEC WandNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-12-23
00812258022242MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022259MAGEC WandNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022723MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022839External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15