Adult Sump Sucker 201090-000

GUDID B0662010900006

A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

NOVOSCI CORP.

Surgical irrigation/aspiration handpiece, single-use
Primary Device IDB0662010900006
NIH Device Record Key2eb83f04-bdee-43cb-9afe-af432bee555a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Sump Sucker
Version Model Number201090-000
Catalog Number201090-000
Company DUNS938289980
Company NameNOVOSCI CORP.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com
Phone800-854-0567
Emailinfo@novosci.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0662010900000 [Primary]
HIBCCB0662010900003 [Package]
Contains: B0662010900000
Package: Inner Carton [25 Units]
In Commercial Distribution
HIBCCB0662010900004 [Package]
Contains: B0662010900000
Package: Partial Case [50 Units]
In Commercial Distribution
HIBCCB0662010900005 [Package]
Contains: B0662010900000
Package: Partial Case [75 Units]
In Commercial Distribution
HIBCCB0662010900006 [Package]
Contains: B0662010900000
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-09-26

On-Brand Devices [Adult Sump Sucker]

B066201090NS3An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from
B0662010900006A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile

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