Infant Grooved Tip Sucker 201037-000

GUDID B0662010370006

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 Surgical irrigation/aspiration handpiece, single-use General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum General-purpose surgical suction system, vacuum
Primary Device IDB0662010370006
NIH Device Record Key689ae7d9-88c5-404f-8e6a-6b83ebf26a30
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfant Grooved Tip Sucker
Version Model Number201037-000
Catalog Number201037-000
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
HIBCCB0662010370000 [Primary]
HIBCCB0662010370003 [Package]
Contains: B0662010370000
Package: Inner Carton [25 Units]
In Commercial Distribution
HIBCCB0662010370004 [Package]
Contains: B0662010370000
Package: Partial Case [50 Units]
In Commercial Distribution
HIBCCB0662010370005 [Package]
Contains: B0662010370000
Package: Partial Case [75 Units]
In Commercial Distribution
HIBCCB0662010370006 [Package]
Contains: B0662010370000
Package: Partial 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

Devices Manufactured by NOVOSCI CORP.

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B0663011240000 - QUICKIE PRIME - 24" W/CLAMP2022-03-09 A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the ext
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