FDA.reportPublic FDA data

Health Support

Primary DI
00078301211227
Brand
Health Support
Company
Carolon Company
Model
Thigh
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FWLCamera, Cine, Endoscopic, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWLCamera, Cine, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00078301211227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078301211227000783012112270783012112270078301211227

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061789731
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00078301871032Couture EssenceBelow Knee08101132024-02-01
00078301871131Couture EssenceBelow Knee08111132024-02-01
00078301871148Couture EssenceBelow Knee08111042024-02-01
00078301871230Couture EssenceBelow Knee08112132024-02-01
00078301871247Couture EssenceBelow Knee08112042024-02-01
00078301871339Couture EssenceBelow Knee08113132024-02-01
00078301871346Couture EssenceBelow Knee08113042024-02-01
00078301871438Couture EssenceBelow Knee08114132024-02-01
00078301871445Couture EssenceBelow Knee08114042024-02-01
00078301872039Couture EssenceBelow Knee08102132024-02-01
00078301873036Couture EssenceBelow Knee08103132024-02-01
00078301874033Couture EssenceBelow Knee08104132024-02-01
00078301881031Couture EssenceThigh08201132024-02-01
00078301881048Couture EssenceThigh08201042024-02-01
00078301881130Couture EssenceThigh08211132024-02-01
00078301881147Couture EssenceThigh08211042024-02-01
00078301881239Couture EssenceThigh08212132024-02-01
00078301881246Couture EssenceThigh08812042024-02-01
00078301881338Couture EssenceThigh08213132024-02-01
00078301881345Couture EssenceThigh08213042024-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319758977Hayden MedicalHayden Medical, Inc.FWL2026-04-23
08908025548083UnivLabs UNIVLABS TECHNOLOGIES PRIVATE LIMITEDFWL2025-07-01
00840319757963Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757970Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757321Hayden MedicalHayden Medical, Inc.FWL2024-06-27
08800033200048ITS Model-L6KInTheSmart Co., Ltd.FWL2022-11-11
00851289007224Firefly Firefly GlobalFWL2022-09-20
00860006918705ProsidioProsidio LLCFWL2021-06-06
00857326005567FocESSSTRYKER CORPORATIONFWL2020-09-18
00863333000327DUROSCOPEFMD, LLCFWL2019-02-09
00863333000334DUROSCOPEFMD, LLCFWL2019-02-09
00863333000358DUROSCOPEFMD, LLCFWL2019-02-09
86333300030188DUROSCOPEFMD, LLCFWL2019-02-09
86333300030218DUROSCOPEFMD, LLCFWL2019-02-09
86333300030232DUROSCOPEFMD, LLCFWL2019-02-09
B1778020RF0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-10-18
B1778007I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778008I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778009I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778013I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778019I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778020I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780500Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780520Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
00851289007040RedfinFirefly GlobalFWL2018-08-14
00851289007057FireflyFirefly GlobalFWL2018-08-14
08800033200031ITS Model-LInTheSmart Co., Ltd.FWL2018-06-15
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16