USA Elite System™ Rotating Continuous Flow Resectoscope Inner Sheath

GUDID 00821925008298

Gyrus Acmi, Inc.

Resectoscope Resectoscope Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable

Primary Device ID	00821925008298
NIH Device Record Key	a6877825-17c4-4f4b-8ddd-881692cd7ed8
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Rotating Continuous Flow Resectoscope Inner Sheath
Version Model Number	REXERIS-CF27
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
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	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	00821925008298 [Primary]

FDA Product Code

FEC	OBTURATOR, FOR ENDOSCOPE
HIH	Hysteroscope (And Accessories)