BTC - Medical Equipment

Basic Information

• Brand Name: BTC - Medical Equipment
• Primary DI: 08050038700009
• Version / Model: EDGE M
• Catalog Number: 9110500
• Company Name: BTC SRL
• Labeler DUNS: 387634079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 2
• Public Version Date: 2022-03-21
• Public Version Status: Update
• Public Device Record Key: e363a5ca-f481-4b93-b81a-191b574098a2

Device Description

EDGE M is BTC ultimate concept of Multispecialty Examination and Procedure Chair. It is the result of innovative technical and engineering solutions that enable the Professionals to perform any examination and procedure in the outpatient and/or Ambulatory Surgery Centres. EDGE M is the paramount tool that suits all clinics and private practices in any medical field.

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: 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
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38447	General examination/treatment chair, electric	A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08050038700009	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius