FDA.reportPublic FDA data

SOMA BORNÉO 30''

Primary DI
00667259002737
Brand
SOMA BORNÉO 30''
Company
Silhouet-Tone Corporation
Model
412545
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMNChair And Table, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMNChair And Table, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667259002737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667259002737006672590027376672590027370667259002737

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, manualA non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-340-9456info@silhouettone.com

Regulatory Flags#

DUNS number
242049828
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667259004007Laguna Edge (2M)4120052025-11-12
00667259003963EVOLUTION XHD4110272025-07-09
00667259003970EVOLUTION ST3504111032025-07-09
00667259001952Soli-Lite LG2 Spectra4115602018-08-24
00667259001600PR Cell 2G4113212018-08-24
00667259003871ELITE PLATINUM LINAK (BI-V)4122682022-07-19
00667259001563ST2504111012018-08-24
00667259003796EVOLUTION 7HD SEQUENTIAL4110172018-09-17
00667259003901ELITE SERIE MD-100 W/O Accessories Table4122522021-09-09
00667259003918ELITE SERIE MD-100-With 2 Arm Support Table4122532021-09-09
00667259003925ELITE SERIE MD-100-With 2 Stirrups Table4122542021-09-09
00667259003932ETNA TABLE (110V) 27 '' 2'' CUSHION WITH HEADREST4127002021-09-09
00667259003949ETNA SBF TABLE (110V) 27'' 2'' CUSHION WITH HEADREST4127162021-09-09
00667259003956ETNA SBF TABLE (110V) 27'' 4'' CUSHION WITH HEADREST4127182021-09-09
00667259003895Soli-Lite LG4 Galileo4115692020-08-17
00667259000030Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000016Laguna Mist 29' 230V4120024120022017-06-16
00667259000443Laguna Mist Flex with Armrest 230V4120044120042017-06-16
00667259000054Laguna Mist 32'' 230V4120144120142017-06-16
00667259003819ELITE SERIE MD-100-With 2 (Stirups & Arm Support) Table4122552019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974847962736JEDHebei Jiede Medical Equipment Co., Ltd.KMN2026-06-04
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionADEPT MEDICAL LIMITEDKMN2026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowADEPT MEDICAL LIMITEDKMN2026-02-09
06973134775172silverfoxSilverfox Corporation LimitedKMN2026-02-05
06970006390105DAYANGGuangdong Dayang Medical Technology Co.,LtdKMN2025-11-20
06974665668216SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
06974665668384SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
00860014524400MP SeatingMP SEATING INCKMN2025-08-19
00860014524417MP SeatingMP SEATING INCKMN2025-08-19
06973134775165silverfoxSilverfox Corporation LimitedKMN2025-07-09
B845CBZ0411WOTUREIntco Medical Industries, Inc.KMN2025-03-28
B845CBZ0413WOTUREIntco Medical Industries, Inc.KMN2025-03-28
09421905187749Adept Medical Retrograde IR Platform - NarrowADEPT MEDICAL LIMITEDKMN2025-03-21
B845CBZ041WOTUREIntco Medical Industries, Inc.KMN2025-03-20
00854798000380Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00854798000410Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00815067013395PROBASICSDrive Devilbiss HealthcareKMN2025-01-20
G53312170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53312370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321250La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321270La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53332170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53333170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53342170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21