KOLPLAST

Basic Information

• Brand Name: KOLPLAST
• Primary DI: 07898027903526
• Version / Model: Standard
• Company Name: Kolplast C I
• Labeler DUNS: 903963889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-13
• Public Version: 1
• Public Version Date: 2019-09-23
• Public Version Status: New
• Public Device Record Key: f56226c8-b831-427d-b2ea-97e0db900eec

Device Description

LED light source for vaginal speculum. Provides illumination during pelvic examination and other gynecological procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898027903526	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110766	000