DynaFuse 5mm Drill

GUDID M97031000100050

Medshape, Inc.

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Primary Device ID	M97031000100050
NIH Device Record Key	a19adb87-33e5-460f-b928-9dfa888dca66
Commercial Distribution Status	In Commercial Distribution
Brand Name	DynaFuse 5mm Drill
Version Model Number	3100-01-0005
Company DUNS	601306413
Company Name	Medshape, 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	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	M97031000100050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203595

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument