Adapter, SIE, Bard-Davol ES3810

GUDID 10815288010903

ENCISION, INC.

Surgical irrigation/aspiration handpiece, reusable
Primary Device ID10815288010903
NIH Device Record Key14f368c3-6648-4bd5-a2dc-7a9606f1ca90
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdapter, SIE, Bard-Davol
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
GS110815288010903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288010903]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-08-31

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