Gimmi

Basic Information

• Brand Name: Gimmi
• Primary DI: 04049047074793
• Version / Model: PU.1678.01
• Catalog Number: PU.1678.01
• Company Name: Gimmi GmbH
• Labeler DUNS: 316152610
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-20
• Public Version: 1
• Public Version Date: 2025-05-28
• Public Version Status: New
• Public Device Record Key: 69604e75-0e1d-4c18-9f53-10f5e7bcab8b

Device Description

KELLY PROCTOSCOPE FIG. 1 Ø 22 MM X 50 MM

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
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15787	Sphincteroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anal sphincter. It is inserted into the body through the anus during a proctological procedure. The inserted portion is very short in length and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are usually viewed by direct vision. This device is used to examine/diagnose patients suffering abnormal functioning of the sphincter, internal haemorrhoids, or anal fissures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049047074793	GS1

Customer Contacts

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