MICASEPT DEBAKEY MIXTER DISSECTING FORCEPS

Basic Information

• Brand Name: MICASEPT DEBAKEY MIXTER DISSECTING FORCEPS
• Primary DI: 00192896091535
• Version / Model: 20920-11-034
• Catalog Number: 20920-11-034
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-22
• Public Version: 1
• Public Version Date: 2018-12-24
• Public Version Status: New
• Public Device Record Key: 6ecb94b3-6644-450a-b822-a5941e6afe9f

Device Description

MICASEPT DEBAKEY MIXTER DISSECTING FORCEPS WITH HAGAR RATCHET CURVED TIP

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
38661	Rigid endoscopic grasping forceps, reusable	A rigid hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument; it is not an electrosurgical instrument. It is typically made of high-grade stainless steel and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896091535	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002877	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.5 Millimeters Tip
Length	300	Millimeter
Device Size Text, specify			60 Degrees Tip