Humeris Shoulder 911-1001

GUDID 03701037304389

TRIAL 3-4 PEGS GLENOID SIZE XS

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037304389
• NIH Device Record Key: ee59f62e-aca0-468a-914b-22a5ddfbfd51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humeris Shoulder
• Version Model Number: 911-1001
• Catalog Number: 911-1001
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037304389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163669

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

[03701037304389]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-07
• Device Publish Date: 2017-05-22

On-Brand Devices [Humeris Shoulder]

• 03701037307144: PROTECTOR Ø39mm WITH SCREW
• 03701037307120: TRIAL CENTERED SPACER Ø35 +5 mm 0°
• 03701037307113: TRIAL CENTERED SPACER Ø35 +3 mm 0°
• 03701037306802: GLENOID CLAMP
• 03701037306789: STOP DRILL BIT Ø7.5 mm L.150 mm/AO
• 03701037306772: STOP DRILL BIT Ø5.0 mm L.150 mm/AO
• 03701037306680: PROTECTOR Ø39mm
• 03701037306673: PROTECTOR WITH GUIDE Ø39mm
• 03701037306666: RASP SIZE 19
• 03701037306659: RASP SIZE 17
• 03701037306642: RASP SIZE 20
• 03701037306635: RASP SIZE 18
• 03701037306628: RASP SIZE 16
• 03701037306611: RASP SIZE 15
• 03701037306604: RASP SIZE 14
• 03701037306598: RASP SIZE 13
• 03701037306581: RASP SIZE 12
• 03701037306574: RASP SIZE 11
• 03701037306567: RASP SIZE 10
• 03701037306550: RASP SIZE 09
• 03701037306543: RASP SIZE 08
• 03701037306499: LEFT CUTTING GUIDES HOLDER
• 03701037306475: RIGHT CUTTING GUIDES HOLDER
• 03701037305584: DRILL BIT Ø3.2mm L.150mm/AO
• 03701037304600: HUMERIS STEM TA6V SIZE 20 CEMENTLESS Ti/HA
• 03701037304594: HUMERIS STEM TA6V SIZE 19 CEMENTLESS Ti/HA
• 03701037304587: HUMERIS STEM TA6V SIZE 18 CEMENTLESS Ti/HA
• 03701037304570: HUMERIS STEM TA6V SIZE 17 CEMENTLESS Ti/HA
• 03701037304563: TRIAL HUMERIS STEM T20
• 03701037304556: TRIAL HUMERIS STEM T19
• 03701037304549: TRIAL HUMERIS STEM T18
• 03701037304532: TRIAL HUMERIS STEM T17
• 03701037304525: TRIAL HUMERIS STEM T16
• 03701037304518: TRIAL HUMERIS STEM T15
• 03701037304501: TRIAL HUMERIS STEM T14
• 03701037304495: TRIAL HUMERIS STEM T13
• 03701037304488: TRIAL HUMERIS STEM T12
• 03701037304471: TRIAL HUMERIS STEM T11
• 03701037304464: TRIAL HUMERIS STEM T10
• 03701037304457: TRIAL HUMERIS STEM T09
• 03701037304440: TRIAL HUMERIS STEM T08
• 03701037304433: TRIAL HUMERIS STEM T07
• 03701037304426: TRIAL HUMERIS STEM T06
• 03701037304419: TRIAL 3-4 PEGS GLENOID SIZE L
• 03701037304402: TRIAL 3-4 PEGS GLENOID SIZE M
• 03701037304396: TRIAL 3-4 PEGS GLENOID SIZE S
• 03701037304389: TRIAL 3-4 PEGS GLENOID SIZE XS
• 03701037304372: TRIAL CENTERED SPACER Ø54 +5 mm 0°
• 03701037304365: TRIAL CENTERED SPACER Ø54 +3 mm 0°
• 03701037304358: TRIAL CENTERED SPACER Ø52 +5 mm 0°