Sun Medical Inc 9120000

GUDID B22691200000

Smoke/Fluid evacuator system

SUN MEDICAL INC

Surgical fluid/smoke waste management system suction unit
Primary Device IDB22691200000
NIH Device Record Keya0105826-885e-418c-8a3b-5facd971372e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSun Medical Inc
Version Model NumberSFE200
Catalog Number9120000
Company DUNS095223103
Company NameSUN MEDICAL 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9033569000
EmailSpolk@sunmedicalinc.com
Phone9033569000
EmailSpolk@sunmedicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB22691200000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-23

On-Brand Devices [Sun Medical Inc]

B226845002Aspirator Tubing with Swivel Handle
B226845000Aspirator Tubing with Swivel Handle
B226844002Aspirator Tubing with adaptor
B226844000Aspirator Tubing with Adaptor
B226843002Disposable Swivel Handle for uses with Aspirator tubing and Cannula
B226843000Disposable Swivel Handle for use with Aspirator Tubing and Cannula
B22684214214mm Curved Cannula
B22684214014mm Curved Cannula
B22684212212mm Curved Cannula
B22684212012mm Curved Canula
B22684210210mm Curved Cannula
B22684210010mm Curved Cannula
B2268420828mm Curved Cannula
B2268420808mm Curved Cannula
B22684114214mm Straight Cannula
B22684114014mm Straight Cannula
B22684112212mm Straight Cannula
B22684112012mm Straight Cannula
B22684110210mm Straight Cannula
B22684110010mm Straight Cannula
B2268410828mm Straight Cannula
B2268410808mm Straight Cannula
B22691200000Smoke/Fluid evacuator system
B22687300001Smoke Evacuator Circiut
B22687300000Smoke Evacuator Circuit
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