PRCT2 100-0206

GUDID 03701037301869

PRCT2, DIAPHYSEAL PLATE TA6V 6 HOLES

FX SOLUTIONS

Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis
Primary Device ID03701037301869
NIH Device Record Key9ff73db3-0f21-4ee5-92f2-e109634ca3db
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRCT2
Version Model Number100-0206
Catalog Number100-0206
Company DUNS263076196
Company NameFX SOLUTIONS
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr
Phone+33474553397
Emailjjmartin@fxsolutions.fr

Device Dimensions

Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter
Length110 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037301869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-07
Device Publish Date2016-06-09

On-Brand Devices [PRCT2]

03701037303429HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 5
03701037303412HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 4
03701037303405HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 3
03701037303399HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 2
03701037303382HUMELOCK INSTRUMENT HUMELOCK TRIAL OFFSET MODULAR SYSTEM SIZE 1
03701037303146PRCT2, PRCT II PLATE TA6V RIGHT 13 HOLES
03701037301906PRCT2, DIAPHYSEAL PLATE TA6V 10 HOLES
03701037301890PRCT2, DIAPHYSEAL PLATE TA6V 9 HOLES
03701037301883PRCT2, DIAPHYSEAL PLATE TA6V 8 HOLES
03701037301876PRCT2, DIAPHYSEAL PLATE TA6V 7 HOLES
03701037301869PRCT2, DIAPHYSEAL PLATE TA6V 6 HOLES
03701037301852DIAPHYSEAL PLATE TA6V 5 HOLES
03701037301845PRCT II HUMERAL PLATE TA6V LEFT, 7 HOLES
03701037301838PRCT II HUMERAL PLATE TA6V LEFT 6 HOLES
03701037301807PRCT2, PRCT II HUMERAL PLATE TA6V LEFT 3 HOLES
03701037301791PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 7 HOLES
03701037301784PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 6 HOLES
03701037301777PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 5 HOLES
03701037301760PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 4 HOLES
03701037301753PRCT2, PRCT II HUMERAL PLATE TA6V RIGHT 3 HOLES
03701037303207PRCT2, PRCT II PLATE TA6V LEFT 13 HOLES
03701037303191PRCT II PLATE TA6V LEFT 12 HOLES
03701037303184PRCT II PLATE TA6V LEFT 11 HOLES
03701037303177PRCT II PLATE TA6V LEFT 10 HOLES
03701037303160PRCT2, PRCT II PLATE TA6V LEFT 9 HOLES
03701037303139PRCT II PLATE TA6V RIGHT 12 HOLES
03701037303115PRCT II PLATE TA6V RIGHT 11 HOLES
03701037303108PRCT2, PRCT II PLATE TA6V RIGHT 9 HOLES
03701037303092PRCT II HUMERALE PLATE TA6V RIGHT 8 HOLES
03701037310939PRCT II PLATE TA6V LEFT 13 HOLES
03701037310922PRCT II PLATE TA6V LEFT 12 HOLES
03701037310915PRCT II PLATE TA6V LEFT 11 HOLES
03701037310908PRCT II PLATE TA6V LEFT 10 HOLES
03701037310892PRCT II PLATE TA6V LEFT 9 HOLES
03701037310885PRCT II HUMERALE PLATE TA6V LEFT 8 HOLES
03701037310861PRCT II PLATE TA6V RIGHT 12 HOLES
03701037310847PRCT II PLATE TA6V RIGHT 11 HOLES
03701037310830PRCT II HUMERALE PLATE TA6V RIGHT 9 HOLES
03701037310823PRCT II HUMERALE PLATE TA6V RIGHT 8 HOLES
03701037301036HUMELOCK II STEM TA6V SIZE 09 CEMENTLESS TI/HA
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