PremierPro Vaginal Speculum

Basic Information

• Brand Name: PremierPro Vaginal Speculum
• Primary DI: 00811220032166
• Version / Model: 5314
• Catalog Number: 5314
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-17
• Public Version: 1
• Public Version Date: 2019-06-25
• Public Version Status: New
• Public Device Record Key: 2700b76f-b92e-491b-b6af-c7ca5932b345

Device Description

Lighted, Size Medium Disposal Methods: Disposal practices must be in compliance with all Federal, State and Local laws and regulations. DO NOT DUMP INTO ANY SEWERS, ON THE GROUND OR INTO ANY BODY OF WATER.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	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 typically 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00811220032180	GS1	Case	4	In Commercial Distribution
Package	00811220032173	GS1	Box	25	In Commercial Distribution
Primary	00811220032166	GS1

Customer Contacts

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