Case 2 Complete

GUDID 00817766026461

Case 2 Complete

Tecomet

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

Primary Device ID	00817766026461
NIH Device Record Key	7829ad0f-4146-405c-9185-05fe0b7ebd82
Commercial Distribution Status	In Commercial Distribution
Brand Name	Case 2 Complete
Version Model Number	2500-00-794
Company DUNS	118087931
Company Name	Tecomet
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	true
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	00817766026461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K012105

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories