TIPCAM

Basic Information

• Brand Name: TIPCAM
• Primary DI: 04048551396018
• Version / Model: 28164AA3D
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f3fe5fc7-bbaf-49dc-b9ed-15f457038f07

Device Description

TIPCAM®1 S 3D, 0°, 4 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
GWG	ENDOSCOPE, NEUROLOGICAL	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35616	Endoscopic video imaging system	An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551396018	GS1

Premarket Submissions

Submission Number	Supplement Number
K162880	000