HUMELOCK REVERSED 903-3214

GUDID 03701037307854

TRIAL HUMELOCK REVERSED STEMI Ø32/14

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

Primary Device ID	03701037307854
NIH Device Record Key	f2762354-857c-4266-8f38-d6b3bd46f278
Commercial Distribution Status	In Commercial Distribution
Brand Name	HUMELOCK REVERSED
Version Model Number	903-3214
Catalog Number	903-3214
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	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
GS1	03701037307854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162455

FDA Product Code

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