Precice External Remote Controller ERC 4P

GUDID 00195377083302

PRECICE ERC 4P

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod adjustment remote control
Primary Device ID00195377083302
NIH Device Record Key02835d90-f693-49cf-9efc-be91099ae9f7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecice External Remote Controller
Version Model NumberERC 4P
Catalog NumberERC 4P
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195377083302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-21
Device Publish Date2021-10-13

On-Brand Devices [Precice External Remote Controller]

00887517059499PRECICE ERC 4P Shipping Pkg GER
00887517059444PRECICE ERC 4P Shipping Pkg AU
00887517059437PRECICE ERC 4P Shipping Pkg EU
00195377083302PRECICE ERC 4P
00195377024343PRECICE ERC 4P Shipping Pkg UK
00887517990105Precice ERC 3P
00887517945327PRECICE ERC 3P Shipping Pkg AU
00887517945310PRECICE ERC 3P Shipping Pkg EU
00887517945303PRECICE ERC 3P Shipping Pkg UK
00195377099105Precice ERC 2P
00195377097309PRECICE Prescription Program

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