AEM® Disposable Low Profile Scissors ES0120

GUDID 10815288010651

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID10815288010651
NIH Device Record Key8117169b-2559-4aaa-ac0e-5550fea8f4ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEM® Disposable Low Profile Scissors
Version Model NumberES0120
Catalog NumberES0120
Company DUNS612250175
Company NameENCISION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length35 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288010651 [Primary]
GS120815288010658 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2016-08-31

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