R1 Reverse Shoulder System

GUDID 00811596030971

Poly Trial 40mm +4mm

CATALYST ORTHOSCIENCE INC.

Shoulder reverse/standard adaptor prosthesis trial
Primary Device ID00811596030971
NIH Device Record Keycddacca0-d8b5-425c-80f4-d43586689741
Commercial Distribution StatusIn Commercial Distribution
Brand NameR1 Reverse Shoulder System
Version Model Number1230-4213-002
Company DUNS079702565
Company NameCATALYST ORTHOSCIENCE INC.
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

Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com
Phone800-587-5137
Emailinfo@catalystortho.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.
Special Storage Condition, SpecifyBetween 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811596030971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


[00811596030971]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-11
Device Publish Date2021-03-03

On-Brand Devices [R1 Reverse Shoulder System]

00811596030728Glenosphere Locking Screw
00811596030711Glenosphere 40mm - Lateral
00811596030704Glenosphere 40mm - Standard
00811596030698Glenosphere 36mm - Lateral
00811596030681Glenosphere 36mm - Standard
00811596030674Glenosphere 32mm - Lateral
00811596030667Glenosphere 32mm - Standard
00811596030650Peripheral Screw 4.5mm - 36mm
00811596030643Peripheral Screw 4.5mm - 32mm
00811596030636Peripheral Screw 4.5mm - 28mm
00811596030629Peripheral Screw 4.5mm - 24mm
00811596030612Peripheral Screw 4.5mm - 20mm
00811596030605Peripheral Screw 4.5mm - 16mm
00811596030599Peripheral Screw 4.5mm - 12mm
00811596030582Center Post 6.5mm - 35mm
00811596030575Center Post 6.5mm - 25mm
00811596030568Center Screw 6.5mm - 40mm
00811596030551Center Screw 6.5mm - 30mm
00811596030544Center Screw 6.5mm - 20mm
00811596030537Augmented Baseplate 10°
00811596030520Standard Baseplate
00811596030513Poly Insert 40mm +12
00811596030506Poly Insert 40mm +8
00811596030490Poly Insert 40mm +4
00811596030483Poly Insert 40mm +0
00811596030476Poly Insert 36mm +12
00811596030469Poly Insert 36mm +8
00811596030452Poly Insert 36mm +4
00811596030445Poly Insert 36mm +0
00811596030438Poly Insert 32mm +12
00811596030421Poly Insert 32mm +8
00811596030414Poly Insert 32mm +4
00811596030407Poly Insert 32mm +0
00811596030391Humeral Stem Long - 41mm
00811596030384Humeral Stem Long - 36mm
00811596030377Humeral Stem Short - 41mm
00811596030360Humeral Stem Short - 36mm
00811596030896Long Broach 36mm
00811596030889Short Broach 41mm
00811596030872Short Broach 36mm
00811596030865Stem Handle ASM
00811596030858Humeral Drill
00811596030841Humeral Drill Guide 41mm
00811596030834Humeral Drill Guide 36mm
00811596030827Reamer Drive Shaft
00811596030810Reamer Head 41mm
00811596030803Reamer Head 36mm
00811596030797Reamer Guide Plate 41mm
00811596030780Reamer Guide Plate 36mm
00811596030773Humeral Head Protector

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