ProMade Shoulder 9CCS.13.442

GUDID 08033390254847

PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm

LIMACORPORATE SPA

Reverse shoulder head prosthesis trial
Primary Device ID08033390254847
NIH Device Record Key772f7f6b-d448-4e0d-a7cb-2f4b91b61970
Commercial Distribution StatusIn Commercial Distribution
Brand NameProMade Shoulder
Version Model Number9CCS.13.442
Catalog Number9CCS.13.442
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390254847 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


[08033390254847]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-18
Device Publish Date2023-05-10

On-Brand Devices [ProMade Shoulder]

08033390254878PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm ECC.
08033390254861PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm ECC.
08033390254854PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm ECC.
08033390254847PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm
08033390254823PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm
08033390254793PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm
08033390282659ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm
08033390282642ProMade Shoulder - Long Helix Drill Dia. 3,5 mm

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