MICTEC SPRAY NOZZLE

Basic Information

• Brand Name: MICTEC SPRAY NOZZLE
• Primary DI: 00192896008854
• Version / Model: 20943-54
• Catalog Number: 20943-54
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-15
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: c55c015c-3b6f-4beb-ba89-45c04d0e19bb

Device Description

MICTEC SPRAY NOZZLE BODY PART, ROTABLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64236	Medication spray nozzle	A tubular device with an atomizing distal tip intended to be attached to the container (e.g., squeeze bottle, syringe) of a medication (e.g., local anaesthetic) [not included] for administration of the medication in spray (atomized) form. It may be used externally (i.e., on skin) and/or non-surgical invasively via a natural orifice (e.g., oral, laryngeal) during a clinical procedure (e.g., endotracheal intubation, prior to percutaneous injection); it is typically made of polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896008854	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002877	000