Shoulder Innovations TSA System 2N1GD00027

GUDID B1132N1GD000270

Instrument. Anatomic Sizer Disk - 27mm

SHOULDER INNOVATIONS, LLC

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• Primary Device ID: B1132N1GD000270
• NIH Device Record Key: 1b991955-c022-4f90-8d68-143f411b1b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations TSA System
• Version Model Number: Anatomic Sizer Disk - 27mm
• Catalog Number: 2N1GD00027
• Company DUNS: 080404519
• Company Name: SHOULDER INNOVATIONS, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132N1GD000270 [Primary]

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

[B1132N1GD000270]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-25
• Device Publish Date: 2021-02-17

On-Brand Devices [Shoulder Innovations TSA System]

• B1130SIGR220650: REAMER/DRILL 22MM
• B1130S1SS141300: HUMERAL STEM TRIAL 14MM X 130MM
• B1130S1SS121300: HUMERAL STEM TRIAL 12MM X 130MM
• B1130S1SS101300: HUMERAL STEM TRIAL 10MM X 130MM
• B1130S1SS081300: HUMERAL STEM TRIAL 8MM X 130MM
• B1130S1SS061300: HUMERAL STEM TRIAL 6MM X 130MM
• B1130S1IV000000: VERSION CONTROL HANDLE
• B1130S1IT000000: HUMERAL MULTI PURPOSE TOOL
• B1130S1IR000140: CANAL REAMER 14MM
• B1130S1IR000120: CANAL REAMER 12MM
• B1130S1IR000100: CANAL REAMER 10MM
• B1130S1IR000080: CANAL REAMER 8MM
• B1130S1IR000060: CANAL REAMER 6MM
• B1130S1II000000: IMPACTION STAND
• B1130S1IH000000: IMPACTION HEAD
• B1130S1IF000000: T HANDLE
• B1130S1ID000000: HUMERAL HEAD DISTRACTOR
• B1130S1IC000000: INSTRUMENT CASE
• B1130S1IB000000: HUMERAL HEAD GAUGE
• B1130S1IA000000: HUMERAL HEAD CUT GUIDE
• B1130S1HO230520: HUMERAL HEAD TRIAL 23MM X 52MM
• B1130S1HO210520: HUMERAL HEAD TRIAL 21MM X 52MM
• B1130S1HO210460: HUMERAL HEAD TRIAL 21MM X 46MM
• B1130S1HO190520: HUMERAL HEAD TRIAL 19MM X 52MM
• B1130S1HO190460: HUMERAL HEAD TRIAL 19MM X 46MM
• B1130S1HO170520: HUMERAL HEAD TRIAL 17MM X 52MM
• B1130S1HO170460: HUMERAL HEAD TRIAL 17MM X 46MM
• B1130S1HO170400: HUMERAL HEAD TRIAL 17MM X 40MM
• B1130S1HO150460: HUMERAL HEAD TRIAL 15MM X 46MM
• B1130S1HO150400: HUMERAL HEAD TRIAL 15MM X 40MM
• B1130S1GW000000: REAMER WRENCH
• B1130S1GT000000: IMPLANT/TRIAL GRASPER
• B1130S1GS000040: Glenoid Driver Grip
• B1130S1GR300650: REAMER/DRILL 30MM
• B1130S1GR270650: REAMER/DRILL 27MM
• B1130S1GR240650: REAMER/DRILL 24MM
• B1130S1GK00020: K WIRE
• B1130S1GG000300: Peripherla Drill Guide 30mm
• B1130S1GG000270: Peripheral Drill Guide 27mm
• B1130S1GG000240: Peripheral Drill Guide 24mm
• B1130S1GG000220: Peripheral Drill Guide 22mm
• B1130S1GG000020: PERIPHERAL DRILL GUIDE HANDLE
• B1130S1GD270300: SIZER DISK 27 + 30
• B1130S1GD220240: Sizer Disk 22 + 24mm
• B1130S1GC000020: Center Drill
• B1130S1GC000010: Center Drill Cannulated
• B1130S1GB000000: GLENOID IMPACTOR
• B1130S1GA000000: ANTI ROTATION PEG
• B1130S1CI300080: GLENOID TRIAL 30MM X 8MM
• B1130S1CI300060: GLENOID TRIAL 30MM X 6MM