ZENEX SURGERY KIT

GUDID 08800070233283

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Primary Device ID	08800070233283
NIH Device Record Key	f4808905-f825-4245-a81e-56be44f0c65f
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZENEX SURGERY KIT
Version Model Number	ZENSGATKIT
Company DUNS	694625347
Company Name	Izenimplant Co., Ltd.
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	true
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	08800070233283 [Primary]

FDA Product Code

NDP	Accessories, Implant, Dental, Endosseous