Pediatric Grooved Tip Sucker 201036-000

GUDID B0662010360006

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 Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use Surgical irrigation/aspiration handpiece, single-use

• Primary Device ID: B0662010360006
• NIH Device Record Key: 2ce9b764-42dd-4afb-b32e-fa5fac4b8109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Grooved Tip Sucker
• Version Model Number: 201036-000
• Catalog Number: 201036-000
• Company DUNS: 938289980
• Company Name: NOVOSCI CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0662010360000 [Primary]
HIBCC	B0662010360003 [Package]; Contains: B0662010360000; Package: Inner Carton [25 Units]; In Commercial Distribution
HIBCC	B0662010360004 [Package]; Contains: B0662010360000; Package: Partial Case [50 Units]; In Commercial Distribution
HIBCC	B0662010360005 [Package]; Contains: B0662010360000; Package: Partial Case [75 Units]; In Commercial Distribution
HIBCC	B0662010360006 [Package]; Contains: B0662010360000; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801400

FDA Product Code

• DTS: Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-26

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