MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP

Basic Information

• Brand Name: MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP
• Primary DI: B09920919080740
• Version / Model: 20919-08-074
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 6ad158e5-b87a-475f-b514-448a3f0e7eb0
• Distribution End Date: 2018-09-22

Device Description

MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP WITH HEGAR RATCHET CURVED

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	B09920919080740	HIBCC

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			6mm Diameter
Device Size Text, specify			100mm 45° Jaw
Length	300	Millimeter