5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation

GUDID 10815288014123

ENCISION, INC.

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Primary Device ID	10815288014123
NIH Device Record Key	4694aa0b-8fc2-4b7d-a724-1cadbbcda759
Commercial Distribution Status	In Commercial Distribution
Brand Name	5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation
Version Model Number	EP3460-45RR
Company DUNS	612250175
Company Name	ENCISION, 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	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 Dimensions

Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288014123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K925079

FDA Product Code

HET	Laparoscope, Gynecologic (And Accessories)