Pediatric Grooved Tip Sucker - A hand-held device designed to regulate and - NOVOSCI CORP.

Duns Number:938289980

Device Description: A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., st 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.

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More Product Details

Catalog Number

201036-000

Brand Name

Pediatric Grooved Tip Sucker

Version/Model Number

201036-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K801400,K801400,K801400,K801400,K801400

Product Code Details

Product Code

DTS

Product Code Name

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

2ce9b764-42dd-4afb-b32e-fa5fac4b8109

Public Version Date

August 21, 2019

Public Version Number

5

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

B0662010360006

Quantity per Package

100

Contains DI Package

B0662010360000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NOVOSCI CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50