FDA.reportPublic FDA data

Couture Essence

Primary DI
00078301881130
Brand
Couture Essence
Company
Carolon Company
Model
Thigh
Catalog number
0821113
Published
2024-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00078301881130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078301881130000783018811300783018811300078301881130

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
Manufacturing date on label
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
00078301881147Couture EssenceThigh08211042024-02-01
00078301881239Couture EssenceThigh08212132024-02-01
00078301881246Couture EssenceThigh08812042024-02-01
00078301881338Couture EssenceThigh08213132024-02-01
00078301881345Couture EssenceThigh08213042024-02-01
00078301881437Couture EssenceThigh08214132024-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496074489SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074496SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074502SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074519SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074526SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074533SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074540SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074557SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074564SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
00674854000013SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCFQL2018-12-31