ATEC Light Cable System

GUDID 00190376508085

LIF Illumination System, Sterile

ALPHATEC SPINE, INC.

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Primary Device ID00190376508085
NIH Device Record Key16e557f1-23ac-421c-ae3a-302833792975
Commercial Distribution StatusIn Commercial Distribution
Brand NameATEC Light Cable System
Version Model Number169-510-S
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Datetrue
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
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
GS100190376508085 [Primary]

FDA Product Code

FDGRetractor, fiberoptic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


[00190376508085]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-12
Device Publish Date2024-02-02

On-Brand Devices [ATEC Light Cable System]

00190376508092MIS Illumination System, Sterile
00190376508085LIF Illumination System, Sterile

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