MICTEC DISSECTION SPATULA

Basic Information

• Brand Name: MICTEC DISSECTION SPATULA
• Primary DI: 00192896008762
• Version / Model: 20942-10
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-24
• Public Version: 1
• Public Version Date: 2018-09-24
• Public Version Status: New
• Public Device Record Key: 796d4a00-3ee8-4ab6-ab16-fca78900b3b8

Device Description

MICTEC DISSECTION SPATULA SEMI-SHARP CURVED UP

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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36083	Laparoscopic dissection spatula	A rigid laparoscopic device designed for the blunt dissection of broadly implanted adhesions during a therapeutic laparoscopy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	B09920942100	HIBCC
Primary	00192896008762	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002877	000

Device Sizes

Type	Value	Unit	Text
Length	300	Millimeter