Humelock Cemented Shoulder Prosthesis 926-1005

GUDID 03701037306949

TRIAL CENTERED HEAD 41x15

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03701037306949
NIH Device Record Key0a659fa5-a96c-4c8f-9074-8cb9ba8b41b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumelock Cemented Shoulder Prosthesis
Version Model Number926-1005
Catalog Number926-1005
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 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

Device Dimensions

Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 Millimeter
Outer Diameter41 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
GS103701037306949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

[03701037306949]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-10-07
Device Publish Date2018-09-17

On-Brand Devices [Humelock Cemented Shoulder Prosthesis]

03701037306994TRIAL OFFSET HEAD 48x19
03701037306987TRIAL OFFSET HEAD 41x16
03701037306970TRIAL OFFSET HEAD 35x15
03701037306963TRIAL CENTERED HEAD 54X20
03701037306956TRIAL CENTERED HEAD 48x18
03701037306949TRIAL CENTERED HEAD 41x15
03701037306932TRIAL CENTERED HEAD 35x14
03701037305546HUMELOCK RETROVERSION STEM
03701037303634TRIAL OFFSET HEAD 50x20
03701037303627TRIAL OFFSET HEAD 46x18
03701037303603TRIAL OFFSET HEAD 39x15
03701037303597TRIAL CENTERED HEAD 50x19
03701037303580TRIAL CENTERED HEAD 46x17
03701037303573TRIAL CENTERED HEAD 43x16
03701037303566TRIAL CENTERED HEAD 39x14
03701037300497Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 46x18
03701037300480OFFSET HEAD CrCo 43x17
03701037300466Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 39x15
03701037300435Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 50x19
03701037300411Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17
03701037300404Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 43x16
03701037300381Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 39x14
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