BiPolar Hip System

GUDID 10840843102472

Bipolar femoral head outer component, hemiarthroplasty

Primary Device ID	10840843102472
NIH Device Record Key	6d1c7962-c3f4-46d7-8fec-1c99e8f93c30
Commercial Distribution Status	In Commercial Distribution
Brand Name	BiPolar Hip System
Version Model Number	SC1866-48/28
Company DUNS	804792265
Company Name	Stelkast Incorporated
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10840843102472 [Primary]

KWL	Prosthesis, Hip, Hemi-, Femoral, Metal

Steralize Prior To Use	false
Device Is Sterile	true