KERATOR Torque Tip

GUDID 08809488213429

KJMEDITECH.CO.,LTD

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Primary Device ID	08809488213429
NIH Device Record Key	3dc632cf-6fd3-409c-b006-c2ac23fac931
Commercial Distribution Status	In Commercial Distribution
Brand Name	KERATOR Torque Tip
Version Model Number	KMD61
Company DUNS	688476027
Company Name	KJMEDITECH.CO.,LTD
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	true
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	08809488213429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132144

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous