FDA.reportPublic FDA data

External Remote Controller

Primary DI
00812258022839
Brand
External Remote Controller
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
ERC2
Catalog number
EAD-M1-000
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
00812258022839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258022839008122580228398122580228390812258022839

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
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage 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
00887517952219PRECICE® STRYDE SystemSST-010-000SST-010-0002018-10-19
00887517952226PRECICE® STRYDE SystemSST-010-005SST-010-0052018-10-19
00887517952233PRECICE® STRYDE SystemSST-010-010SST-010-0102018-10-19
00887517952240PRECICE® STRYDE SystemSST-010-015SST-010-0152018-10-19
00887517952257PRECICE® STRYDE SystemSST-010-020SST-010-0202018-10-19
00887517952264PRECICE® STRYDE SystemSST-013-000SST-013-0002018-10-19
00887517952271PRECICE® STRYDE SystemSST-013-005SST-013-0052018-10-19
00887517952288PRECICE® STRYDE SystemSST-013-010SST-013-0102018-10-19
00887517952295PRECICE® STRYDE SystemSST-013-015SST-013-0152018-10-19
00887517952301PRECICE® STRYDE SystemSST-013-020SST-013-0202018-10-19
00887517001139PRECICE® Intramedullary Limb Lengthening SystemCPA2-000CPA2-0002017-10-10
00887517001146PRECICE® Intramedullary Limb Lengthening SystemCPA2-005CPA2-0052017-10-10
00887517001153PRECICE® Intramedullary Limb Lengthening SystemCPA2-010CPA2-0102017-10-10
00887517001160PRECICE® Intramedullary Limb Lengthening SystemCPA2-015CPA2-0152017-10-10
00887517001177PRECICE® Intramedullary Limb Lengthening SystemCPA2-020CPA2-0202017-10-10
00887517001184PRECICE® Intramedullary Limb Lengthening SystemCPA3-000CPA3-0002017-10-10
00887517001191PRECICE® Intramedullary Limb Lengthening SystemCPA3-005CPA3-0052017-10-10
00887517001207PRECICE® Intramedullary Limb Lengthening SystemCPA3-010CPA3-0102017-10-10
00887517001214PRECICE® Intramedullary Limb Lengthening SystemCPA3-015CPA3-0152017-10-10
00887517001221PRECICE® Intramedullary Limb Lengthening SystemCPA3-020CPA3-0202017-10-10

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
00856719002107External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
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