Realstar Surgical

Basic Information

• Brand Name: Realstar Surgical
• Primary DI: 00850071684124
• Version / Model: RSSI-20-130-211
• Company Name: REAL STAR SURGICAL INSTRUMENTS
• Labeler DUNS: 645842282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-12
• Public Version: 1
• Public Version Date: 2025-01-20
• Public Version Status: New
• Public Device Record Key: af6d0354-354a-4534-9877-4b71871983b4

Device Description

4-Way Expander (Large)

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
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35352	Vaginal speculum, reusable	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850071684124	GS1