Brünings loupe head

Basic Information

• Brand Name: Brünings loupe head
• Primary DI: 04050659354517
• Version / Model: 10-182-04
• Catalog Number: 10-182-04
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-09
• Public Version: 1
• Public Version Date: 2022-09-19
• Public Version Status: New
• Public Device Record Key: 3fd1ff4d-cd94-4cc7-8588-bb35bb7b9fd4

Device Description

closed, without magnification

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKC	Spectacle microscope, low-vision	Ophthalmic	886.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30045	Hand-held magnifier	A magnifying ophthalmic lens with a handle intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050659354517	GS1

Customer Contacts

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