Shoulder Innovations Inset Reverse Total Shoulder 2R1GSC0042

GUDID B1132R1GSC00420

Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x 0mm.

Shoulder Innovations, Inc.

Total shoulder prosthesis

• Primary Device ID: B1132R1GSC00420
• NIH Device Record Key: 0bc8031c-ce69-419c-be12-a49882de4fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations Inset Reverse Total Shoulder
• Version Model Number: Standard Glenosphere 42mm x 0mm x 0mm
• Catalog Number: 2R1GSC0042
• Company DUNS: 080404519
• Company Name: Shoulder Innovations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com
• Phone: 616.294.1026
• Email: info@shoulderinnovations.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132R1GSC00420 [Primary]

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

[B1132R1GSC00420]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [Shoulder Innovations Inset Reverse Total Shoulder]

• B1132R1P1203390: Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 39mm Diameter, +3 m
• B1132R1P1203360: Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 36mm Diameter, +3 m
• B1132R1P1203330: Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 33mm Diameter, +3 m
• B1132R1P1000390: Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 39mm Diameter, 0 m
• B1132R1P1000360: Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 36mm Diameter, 0 m
• B1132R1P1000330: Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 33mm Diameter, 0 m
• B1132R1M3806010: Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 6mm.
• B1132R1M3800010: Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 0mm. Titanium
• B1132R1GSC00420: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x 0mm.
• B1132R1GSC00390: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x 0mm.
• B1132R1GSC00360: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x 0mm.
• B1132R1GSC00330: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x 0mm.
• B1132R1GLC06420: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +63mm.
• B1132R1GLC06390: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +6mm.
• B1132R1GLC06360: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +6mm.
• B1132R1GLC03420: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +3mm.
• B1132R1GLC03390: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +3mm.
• B1132R1GLC03360: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +3mm.
• B1132R1GLC03330: Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x +3mm.
• B1132R1R2715250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree
• B1132R1R2715150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree
• B1132R1R2710250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree
• B1132R1R2710150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree
• B1132R1R2705250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree,
• B1132R1R2705150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree,
• B1132R1R2700250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree,
• B1132R1R2700150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree,
• B1132R1R2415250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree
• B1132R1R2415150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree
• B1132R1R2410250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree
• B1132R1R2410150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree
• B1132R1R2405250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree,
• B1132R1R2405150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree,
• B1132R1R2400250: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree,
• B1132R1R2400150: Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree,
• B1132R1P1505390: Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 39mm Diamete
• B1132R1P1505360: Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 36mm Diamete
• B1132R1P1505330: Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 33mm Diamete
• B1132R1GN516420: Shoulder Innovations Inset Reverse Total Shoulder - RSA Baseplate Set Screw Locking Nut (Long)
• B1132R1GN516410: Shoulder Innovations Inset Reverse Total Shoulder - RSA Locking Nut/Set Screw (Medium)
• B1132R1GB407260: Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt - Medium/Long
• B1132R1GB407200: Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt STD-ECC
• B1132R2HR350020: Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Reamer Guide Post
• B1132R2HR350000: Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Convex Reamer
• B1132R2HI000300: Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock Base Assembly
• B1132R2HI000200: Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock T-Handle Assembly
• B1132R2HC100030: Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy Lid
• B1132R2HC100020: Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy
• B1132R2HC100010: Shoulder Innovations Inset Reverse Total Shoulder - RSA Tray
• B1132R2HC100000: Shoulder Innovations Inset Reverse Total Shoulder - RSA Case Base