JARVIS Diaphyseal Stem Standard

GUDID 03661489723544

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489723544
• NIH Device Record Key: 91e4d0a4-8262-4bd5-b1eb-69e300143240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JARVIS Diaphyseal Stem Standard
• Version Model Number: 272354 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D9
• Company DUNS: 261839898
• Company Name: FOURNITURES HOSPITALIERES INDUSTRIE
• 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: true
• 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

Customer Support Contacts

• Phone: +33298556895
• Email: n.rahimi@fhortho.com
• Phone: +33298556895
• Email: n.rahimi@fhortho.com
• Phone: +33298556895
• Email: n.rahimi@fhortho.com
• Phone: +33298556895
• Email: n.rahimi@fhortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661489723544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253345

FDA Product Code

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

Sterilization

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

[03661489723544]

Moist Heat or Steam Sterilization

[03661489723544]

Moist Heat or Steam Sterilization

[03661489723544]

Moist Heat or Steam Sterilization

[03661489723544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-24
• Device Publish Date: 2025-12-16

On-Brand Devices [JARVIS Diaphyseal Stem Standard]

• 03661489723605: 272360 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D15
• 03661489723599: 272359 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D14
• 03661489723582: 272358 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D13
• 03661489723575: 272357 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D12
• 03661489723568: 272356 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D11
• 03661489723551: 272355 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D10
• 03661489723544: 272354 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D9
• 03661489723537: 272353 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D8
• 03661489723506: 272350 - JARVIS DIAPHYSEAL STEM STANDARD D16 L95
• 03661489723490: 272349 - JARVIS DIAPHYSEAL STEM STANDARD D15 L95
• 03661489723483: 272348 - JARVIS DIAPHYSEAL STEM STANDARD D14 L95
• 03661489723476: 272347 - JARVIS DIAPHYSEAL STEM STANDARD D13 L95
• 03661489723469: 272346 - JARVIS DIAPHYSEAL STEM STANDARD D12 L95
• 03661489723452: 272345 - JARVIS DIAPHYSEAL STEM STANDARD D11 L95
• 03661489723445: 272344 - JARVIS DIAPHYSEAL STEM STANDARD D10 L95
• 03661489723438: 272343 - JARVIS DIAPHYSEAL STEM STANDARD D9 L95
• 03661489723421: 272342 - JARVIS DIAPHYSEAL STEM STANDARD D8 L95
• 03661489523618: 272361 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D16