SMR Resurfacing System 9013.17.020

GUDID 08033390038423

Trial Stem Dia.13mm

LIMACORPORATE SPA

Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable

Primary Device ID	08033390038423
NIH Device Record Key	3d88e95b-a5f5-45c1-b417-3435e62a0517
Commercial Distribution Status	In Commercial Distribution
Brand Name	SMR Resurfacing System
Version Model Number	Trial Stem
Catalog Number	9013.17.020
Company DUNS	432066322
Company Name	LIMACORPORATE SPA
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 Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390038423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112900

FDA Product Code

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