FDA.reportPublic FDA data

Carolon CAP

Primary DI
00078301005604
Brand
Carolon CAP
Company
Carolon Company
Model
Knee
Catalog number
560
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00078301005604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078301005604000783010056040783010056040078301005604

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
No natural rubber latex
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
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515485Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515492Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515508Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515515Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515522Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515539Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515546Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515553Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00850073571385American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571392American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571415American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571422American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571446American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571453American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571477American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571484American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04