FDA.reportPublic FDA data

BTC - Medical Equipment

Primary DI
08050038700009
Brand
BTC - Medical Equipment
Company
BTC SRL
Model
EDGE M
Catalog number
9110500
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.
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038700009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038700009080500387000098050038700009

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, electricA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390542643664btcmed@btc-med.it

Regulatory Flags#

DUNS number
387634079
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038700016BTC - Medical EquipmentEDGE P91105012021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544188COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.GBB2026-09-18
06975582544195COINFYCAREHuangshan Jinfu Medical Equipment Co.,Ltd.GBB2026-09-18
M368FR601EPCHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCHBN96071LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCNBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCNNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCOBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPCONN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNHNN86021LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNBN86041LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNNN03171LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNNNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNOBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNONN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EPNONN13111LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EUCHBN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368FR601EUCHNN04271LUMEXGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCHBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCHNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCNBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCNNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCOBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPCONNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHBNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHNN86021INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18
M368IN601EPNHNNCOM1INTENSAGF HEALTH PRODUCTS, INC.GBB2026-09-18