Sterilization Tray

GUDID M896IBIT00010

ARTERIOCYTE MEDICAL SYSTEMS, INC.

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Primary Device ID	M896IBIT00010
NIH Device Record Key	519a2082-202f-4b10-85e1-8b09edb2fadf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sterilization Tray
Version Model Number	IB-IT-0001
Company DUNS	809012870
Company Name	ARTERIOCYTE MEDICAL SYSTEMS, INC.
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	false
Serial Number	true
Manufacturing Date	false
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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896IBIT00010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171520

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories