n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551045244
• Version / Model: 10101FA
• 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: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 51b32d16-0a12-45b9-a52d-2255a3c9477c

Device Description

Prismatic Light Deflector

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: No
• Has Lot/Batch Number: Yes
• 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
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32719	Diagnostic ophthalmic prism	A transparent geometrical device intended to use light refraction principles to assist in the diagnosis of visual problems, especially those associated with ocular muscles (e.g., reduced convergence or accommodation). It is available in various forms such as a bar with multiple prisms of graduated powers, or a single prism on a handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551045244	GS1

Premarket Submissions

Submission Number	Supplement Number
K943700	000