FDA.reportPublic FDA data

DARCO® DCS Plantar Fasciitis sleeve

Primary DI
20609271409259
Brand
DARCO® DCS Plantar Fasciitis sleeve
Company
DARCO INTERNATIONAL, INC.
Model
DCS-PF2-B
Catalog number
DCS-PF2-B
Device description
Medium Black
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10609271409252PackageGS112In Commercial Distribution
20609271409259PackageGS136In Commercial Distribution
00609271409255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927140925210609271409252
2060927140925920609271409259
00609271409255006092714092556092714092550609271409255

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
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496072157SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072164SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072171SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072188SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072195SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072201SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072218SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072225SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072232SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072331SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072348SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072355SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072362SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072379SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072386SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072393SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072409SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072416SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072423SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072430SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072447SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072454SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072461SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072478SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072485SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072492SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072508SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072515SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072522SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072539SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20