SMR 9CCA.13.010

GUDID 08033390111232

SMR : HEMISPHERICAL HUMERAL REAMER Ø42mm

LIMACORPORATE SPA

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable

Primary Device ID	08033390111232
NIH Device Record Key	61bde661-55a4-4a44-a36d-ee6526f63bda
Commercial Distribution Status	In Commercial Distribution
Brand Name	SMR
Version Model Number	HEMISPHERICAL HUMERAL REAMER
Catalog Number	9CCA.13.010
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 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 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 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 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 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	08033390111232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112900

FDA Product Code

KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented