Holders and Positioners - Nathanson Hooks

Basic Information

• Brand Name: Holders and Positioners - Nathanson Hooks
• Primary DI: 00842102113994
• Version / Model: 69711-R9
• Company Name: FLEXBAR MACHINE CORPORATION
• Labeler DUNS: 047644935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-22
• Public Version: 1
• Public Version Date: 2020-07-30
• Public Version Status: New
• Public Device Record Key: f3eed6b2-0707-44f3-a6b2-389e1083205b

Device Description

Nathanson Robotic Retractor Set, Shaft 9cm: 5mm Small, 6.5mm Med & Lg with Long Tip

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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58883	Externally-anchored laparoscopic retractor	A non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842102113994	GS1