Sirocam UAF Plus

Basic Information

• Brand Name: Sirocam UAF Plus
• Primary DI: D7641000064700
• Version / Model: 100006470
• Company Name: SIRONA DENTAL, INC.
• Labeler DUNS: 078613913
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-10
• Public Version: 4
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: b0e9473f-9439-4014-8e5f-4656300f4485
• Distribution End Date: 2022-03-23

Device Description

Sirocam UAF Plus Camera RMA

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
EIA	Unit, Operative Dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40983	Diagnostic-imaging photographic film, self-developing	A self-developing photographic film (e.g., instant or Polaroid) specifically designed for use in a dedicated camera and used for medical or dental imaging applications; especially where it is advantageous to see if the image captured reflects the best possible or intended view of the actual situation of the moment. It is typically designed with specific archival properties that determine the useful life of images captured on the medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7641000064700	HIBCC

Customer Contacts

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