Reinhoff-Burford-Finochietto Pediatric Retractor

Basic Information

• Brand Name: Reinhoff-Burford-Finochietto Pediatric Retractor
• Primary DI: 00192896109094
• Version / Model: 9-5620
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-04
• Public Version: 1
• Public Version Date: 2021-05-12
• Public Version Status: New
• Public Device Record Key: 77d4a3f8-5344-4941-aec0-accbe1b8cae8

Device Description

Reinhoff-Burford-Finochietto Pediatric Retractor

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: Yes
• 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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36302	Laparoscopic mechanical-distention system	An assembly of mechanical devices intended to be used to create a space in the abdominal cavity for laparoscopic procedures by externally lifting the abdominal wall. This isobaric method of lifting the abdominal wall includes the insertion of a retractor, sling, subcutaneous wires or needles and an external lifting mechanism consisting of, e.g., a manual traction device, a support arm clamped to the operating table, or a winch and framework. This device requires no, or minimal, gas insufflation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896109094	GS1

Customer Contacts

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