AEM® Disposable Hook Scissors ES0110

GUDID 10815288010637

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID10815288010637
NIH Device Record Key7da86add-27a3-46f2-9245-1bb089bbe99d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEM® Disposable Hook Scissors
Version Model NumberES0110
Catalog NumberES0110
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
GS110815288010637 [Primary]
GS120815288010634 [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

On-Brand Devices [AEM® Disposable Hook Scissors]

10815288010644ES0110-45
10815288010637ES0110

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