Realstar Surgical

Basic Information

• Brand Name: Realstar Surgical
• Primary DI: 00850071684254
• Version / Model: RSSI-130-150
• Company Name: REAL STAR SURGICAL INSTRUMENTS
• Labeler DUNS: 645842282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 1
• Public Version Date: 2025-01-29
• Public Version Status: New
• Public Device Record Key: 665a3ca4-1f4f-4f63-ba63-7ef597a40f67

Device Description

Rigby 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: 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: 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
HDL	Retractor, Vaginal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66432	Post-parturition vaginal retractor	A dedicated device intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g., suturing) of vaginal tears. It is a non-hinged, self-retaining retractor typically in the form of a polymer sheet/leaflet designed to be bent and inserted into the vagina whereby it self-expands to dilate the vaginal opening. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850071684254	GS1