FDA.reportPublic FDA data

Couture Essence

Primary DI
00078301831234
Brand
Couture Essence
Company
Carolon Company
Model
Tights
Catalog number
831213
Published
2024-01-22
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
00078301831234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078301831234000783018312340783018312340078301831234

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
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI BlackSIGVARIS INCFQL2026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° CaramelSIGVARIS INCFQL2026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° GreySIGVARIS INCFQL2026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI GreySIGVARIS INCFQL2026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI GreySIGVARIS INCFQL2026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° SavannaSIGVARIS INCFQL2026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI SavannaSIGVARIS INCFQL2026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI SavannaSIGVARIS INCFQL2026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° SkinSIGVARIS INCFQL2026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI SkinSIGVARIS INCFQL2026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI SkinSIGVARIS INCFQL2026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marineSIGVARIS INCFQL2026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marineSIGVARIS INCFQL2026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marineSIGVARIS INCFQL2026-05-18
08300496033981SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496071099SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073109SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073116SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073123SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073130SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496073147SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
07613378199295862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° SkinSIGVARIS INCFQL2026-03-25
07613378196195862T-CUSTOM ECF2 AF SoftTop UNI °° BlackSIGVARIS INCFQL2026-03-18
07613378196584862T-CUSTOM ECF2 AF SoftTop UNI BlackSIGVARIS INCFQL2026-03-18
07613378196591862N-CUSTOM ECF2 AF SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-03-18