AEM® Disposable Curved Scissors ES0101

GUDID 10815288010590

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID10815288010590
NIH Device Record Keyfe1709e4-9049-4969-a9ca-7d3e01b08594
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEM® Disposable Curved Scissors
Version Model NumberES0101
Catalog NumberES0101
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
GS110815288010590 [Primary]
GS120815288010597 [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 Curved Scissors]

10815288010620ES0102-45
10815288010613ES0102
10815288010606ES0101-45
10815288010590ES0101

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