DAVIS GALL STONE SCOOP

Basic Information

• Brand Name: DAVIS GALL STONE SCOOP
• Primary DI: 00192896091443
• Version / Model: 1100-521
• Catalog Number: 1100-521
• 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: 3
• Public Version Date: 2022-08-23
• Public Version Status: Update
• Public Device Record Key: 3235734a-6085-4608-abfd-80770405801e

Device Description

DAVIS GALLSTONE SCOOP DOUBLE ENDED BLUNT 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: Yes
• 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: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FHL	SCOOP	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13509	Gallstone scoop	A hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop designs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896091443	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.5	Inch