Adapter, SIE, Applied ES3810

GUDID 10815288010941

ENCISION, INC.

Surgical irrigation/aspiration handpiece, reusable
Primary Device ID10815288010941
NIH Device Record Keya9bf9860-4345-4cf6-800d-83a17e1ae2a7
Commercial Distribution Discontinuation2018-09-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdapter, SIE, Applied
Version Model NumberES3810
Catalog NumberES3810
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288010941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288010941]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-08-31

On-Brand Devices [Adapter, SIE, Applied]

10815288013881ES3850
10815288010941ES3810

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