II Ring Retractor

Basic Information

• Brand Name: II Ring Retractor
• Primary DI: 00810118343100
• Version / Model: Pelvic Surgery System w 1x4" Maleable Blades
• Catalog Number: 1507 SM SS
• Company Name: Automated Medical Products Corp.
• Labeler DUNS: 053435368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-12
• Public Version: 1
• Public Version Date: 2024-03-20
• Public Version Status: New
• Public Device Record Key: 11f598d3-d9a5-4bdb-954d-32779fe626b2

Device Description

Pelvic Surgical Retractor System ; Vaginal Surgical Retractor System 50-4692 with 1"x4" Malleable blades Table Post 12", 1" Post Coupling, Horizontal Flex Bar, 6 Tilt Ratchet Mechanisms, Vaginal Segmented Ring 9.5" x 13.5" Retractors: Lateral Vaginal 1" x 3", Vaginal Posterior 1" x 4.5", Deaver Small 1" x 3.5", Deaver Large 1" x 5" 2 Malleable 1" x 4" with protected edge, 2 Super Malleable 1" x 4" with protected edge

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810118343100	GS1