Pediatric Patient Positioner

GUDID 00190376603582

Lateral Push Arm Pad

ALPHATEC SPINE, INC.

Operating table patient pressure distribution pad, reusable
Primary Device ID00190376603582
NIH Device Record Key723ede0e-cc35-4044-9e40-f269d3ef0eda
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Patient Positioner
Version Model Number551-510
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376603582 [Primary]

FDA Product Code

CCXSUPPORT, PATIENT POSITION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-15
Device Publish Date2025-04-07

On-Brand Devices [Pediatric Patient Positioner]

00190376654959Pediatric Patient Positioner Disposable Kit
00190376603568Pelvic Base, Thin Pad
00190376603551Pelvic Base, Thick Pad
00190376603544Pelvic Lateral, Small Pad
00190376603537Pelvic Lateral, Large Pad
00190376603520Thoracic Lateral, Small Pad
00190376603513Thoracic Lateral, Large Pad
00190376603506Thoracic Base, Right Pad
00190376603490Thoracic Base, Left Pad
00190376603483Thoracic Sizer, Non-Centering, XL
00190376603476Thoracic Sizer, Non-Centering, L
00190376603469Thoracic Sizer, Non-Centering, M
00190376603452Thoracic Sizer, Non-Centering, S
00190376603445Thoracic Sizer, Non-Centering, XS
00190376596433Pelvic Handle L
00190376596426Pelvic Handle R
00190376596402Mirror
00190376596396Sagittal Handle
00190376596389Head Support, Plate
00190376596372Head Support
00190376596365Pelvic Sizer, XL
00190376596358Pelvic Sizer, L
00190376596341Pelvic Sizer, M
00190376596334Pelvic Sizer, S
00190376596327Pelvic Sizer, XS
00190376596310Thoracic Sizer, XL
00190376596303Thoracic Sizer, L
00190376596297Thoracic Sizer, M
00190376596280Thoracic Sizer, S
00190376596273Thoracic Sizer, XS
00190376596266Pelvic Paddle, 90 Degree
00190376596259Pelvic Paddle, 45 Degree
00190376596242Pelvic Paddle, 0 Degree
00190376596235Pelvic Paddle, Small L
00190376596228Pelvic Paddle, Small R
00190376596211Pelvic Paddle, Large L
00190376596204Pelvic Paddle, Large R
00190376596198Thoracic Paddle, Extended L
00190376596181Thoracic Paddle, Extended R
00190376596174Thoracic Paddle, Standard L
00190376596167Thoracic Paddle, Standard R
00190376596150Thoracic Paddle, Small L
00190376596143Thoracic Paddle, Small R
00190376596136Thoracic Paddle, Large L
00190376596129Thoracic Paddle, Large R
00190376596112Pelvic Lateral Carriage Assembly
00190376596105Pelvic Positioner
00190376596099A-Arm Thoracic Lateral Carriage Assembly
00190376596082Thoracic Anterior Plate L
00190376596075Thoracic Anterior Plate R

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