BEE HA MCI618

GUDID 04251631400707

All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.

NGMedical GmbH

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

Primary Device ID	04251631400707
NIH Device Record Key	0a8d8b7a-ca97-4ffe-9726-7ebf81a01624
Commercial Distribution Status	In Commercial Distribution
Brand Name	BEE HA
Version Model Number	MOVE-C Trial 6x18mm
Catalog Number	MCI618
Company DUNS	342615118
Company Name	NGMedical GmbH
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	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	04251631400707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203444

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument