O-RING HEMORRHOID BAND CUTTER

Basic Information

• Brand Name: O-RING HEMORRHOID BAND CUTTER
• Primary DI: 00192896044753
• Version / Model: 508-556
• Catalog Number: 508-556
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-06
• Public Version: 3
• Public Version Date: 2023-07-10
• Public Version Status: Update
• Public Device Record Key: 51fdf33b-8a4e-4c53-8de1-c9a9f2f55287

Device Description

O-RING HEMORRHOID BAND CUTTER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
FZT	Cutter, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44806	Surgical instrument seal/seal maintenance set	A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	B0995085560	HIBCC
Primary	00192896044753	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.5	Inch