Ambassador Cervical Plate System

GUDID 00840996174626

AMBASSADOR,SPLIT T15,TAPERED,MAJOR

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00840996174626
NIH Device Record Keyf88603fb-8c02-477f-bff6-bb60766b0734
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbassador Cervical Plate System
Version Model Number05-109-02-2004
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996174626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


[00840996174626]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-08
Device Publish Date2018-09-07

On-Brand Devices [Ambassador Cervical Plate System]

00840996174633AMBASSADOR,SPLIT T15,TAPERED,MINOR-MAJOR
00840996174626AMBASSADOR,SPLIT T15,TAPERED,MAJOR
00840996174619AMBASSADOR,SPLIT T15,TAPERED,MINOR
00840996174602AMBASSADOR,SPLIT T15,CYL.,MAJOR-MINOR
00840996174596AMBASSADOR,SPLIT T15,CYLINDRICAL,MAJOR
00840996174589AMBASSADOR,SPLIT T15,CYLINDRICAL,MINOR
00840996161411AMBASSADOR,CALIPER 30 to 100MM
00840996161404AMBASSADOR,PLATE HOLDER INSIDE
00840996161398AMBASSADOR,PLATE BENDER
00840996161381AMBASSADOR,AWL SLEEVE
00840996161374AMBASSADOR,DRIVER,SELF,RETAIN,THR,T-15
00840996161367AMBASSADOR,DRIVER,SELF,RETAIN,THR,T-15
00840996161350AMBASSADOR,ACP.TEMPORARY.HOLDING.PIN
00840996161343AMBASSADOR,BAYONET FORCEPS
00840996161336AMBASSADOR,DRILL,2.3x22
00840996161329AMBASSADOR,DRILL,2.3x21
00840996161312AMBASSADOR,DRILL,2.3x20
00840996161305AMBASSADOR,DRILL,2.3x19
00840996161299AMBASSADOR,DRILL,2.3x18
00840996161282AMBASSADOR,DRILL,2.3x17
00840996161275AMBASSADOR,DRILL,2.3x16
00840996161268AMBASSADOR,DRILL,2.3x15
00840996161251AMBASSADOR,DRILL,2.3x14
00840996161244AMBASSADOR,DRILL,2.3x13
00840996161237AMBASSADOR,DRILL,2.3x12
00840996161220AMBASSADOR,DRILL,2.3x11
00840996161213AMBASSADOR,DRILL,2.3x10
00840996161206AMBASSADOR,DRILL,2.0x22
00840996161190AMBASSADOR,DRILL,2.0x21
00840996161183AMBASSADOR,DRILL,2.0x20
00840996161176AMBASSADOR,DRILL,2.0x19
00840996161169AMBASSADOR,DRILL,2.0x18
00840996161152AMBASSADOR,DRILL,2.0x17
00840996161145AMBASSADOR,DRILL,2.0x16
00840996161138AMBASSADOR,DRILL,2.0x15
00840996161121AMBASSADOR,DRILL,2.0x14
00840996161114AMBASSADOR,DRILL,2.0x13
00840996161107AMBASSADOR,DRILL,2.0x12
00840996161091AMBASSADOR,DRILL,2.0x11
00840996161084AMBASSADOR,DRILL,2.0x10
00840996161077AMBASSADOR,DRILL,2.5x22
00840996161060AMBASSADOR,DRILL,2.5x21
00840996161053AMBASSADOR,DRILL,2.5x20
00840996161046AMBASSADOR,DRILL,2.5x19
00840996161039AMBASSADOR,DRILL,2.5x18
00840996161022AMBASSADOR,DRILL,2.5x17
00840996161015AMBASSADOR,DRILL,2.5x16
00840996161008AMBASSADOR,DRILL,2.5x15
00840996160995AMBASSADOR,DRILL,2.5x14
00840996160988AMBASSADOR,DRILL,2.5x13

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