FDA.report

Carolon Couture

Primary DI
00078301710348
Brand
Carolon Couture
Company
Carolon Company
Model
Below Knee
Catalog number
710304
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00078301710348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00078301710348000783017103480783017103480078301710348

GMDN Terms

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

Regulatory Flags

DUNS number
061789731
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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

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Primary DIBrandCompanyProduct codePublished
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08300496072515SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
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