CLAW GRASPING & EXTRACTING FORCEP INSERT

Basic Information

• Brand Name: CLAW GRASPING & EXTRACTING FORCEP INSERT
• Primary DI: B09929012600
• Version / Model: 2901-260
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 7
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8bec97e8-90f4-43e7-be51-bca16089d600
• Distribution End Date: 2018-06-22

Device Description

CLAW GRASPING & EXTRACTING FORCEPS SINGLE-ACTION JAW FOR TUBE SHAFT

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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46374	Vascular Doppler clamp	An instrument with an integrated ultrasound transducer used for the detection and temporary occlusion of blood vessels during a surgical procedure. It is typically a held-hand device that is placed on the vasculature to be affected. It is connected to an appropriate signal receiver, and using the Doppler effect (variation in the frequency of a wave of energy (as measured by an observer) due to relative motion between the observer and the source of the wave), will provide the user with information regarding achieved occlusion of the vessel(s). It is typically used on uterine arteries during laparoscopic myomectomy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B09929012600	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			2x3 Teeth
Length	360	Millimeter
Device Size Text, specify			10mm Shaft