Nella NuSpec

Basic Information

• Brand Name: Nella NuSpec
• Primary DI: 00860000270427
• Version / Model: NU001
• Company Name: CEEK WOMEN'S HEALTH
• Labeler DUNS: 116951931
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-18
• Public Version: 3
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: d7eb014c-15e5-4ccc-9d5a-b90a06f39405

Device Description

Reusable Vaginal Speculum

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: 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: 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", "Ethylene Oxide", "Hydrogen Peroxide", "High-level Disinfectant"]

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
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
Package	10860000270424	GS1	box of 10	10	In Commercial Distribution
Primary	00860000270427	GS1

Customer Contacts

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