Humeral Cup Standard 312-0703

GUDID 03701037310588

HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3

FX SOLUTIONS

Polyethylene reverse shoulder prosthesis cup
Primary Device ID03701037310588
NIH Device Record Key12386ae9-cd7d-4071-9ed8-db14e9f35955
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumeral Cup Standard
Version Model Number312-0703
Catalog Number312-0703
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

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.
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.
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
GS103701037310588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

Devices Manufactured by FX SOLUTIONS

03701037302149 - PRCT II2024-08-14 LOCKING SCREW TA6V Ø4.5mm L.55mm
03701037302194 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.16mm
03701037302200 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.18mm
03701037302286 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.55mm
03701037302576 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.34mm
03701037302590 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.38mm
03701037302606 - PRCT II2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.42mm
03701037320525 - FX V135® Shoulder Prothesis2024-08-13 RESURFACING GLENOID REAMER Ø54mm
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