FDA.reportPublic FDA data

Compression Stocking

Primary DI
G420474
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
474
Catalog number
474
Device description
Leg Band, Below Knee to Ankle
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823737000MADE-TO-MEASURE SURGICAL ELASTIC SUPPORTGotfried Medical, Inc.1983-01-12DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G420474PrimaryHIBCC0

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
038706180
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G420300Compression Stocking3003002023-08-15
G420301Compression Stocking3013012023-08-15
G420302Compression Stocking3023022023-08-15
G420303Compression Stocking3033032023-08-15
G420304Compression Stocking3043042023-08-15
G420305Compression Stocking3053052023-08-15
G420306Compression Stocking3063062023-08-15
G420307Compression Stocking3073072023-08-15
G420308Compression Stocking3083082023-08-15
G420309Compression Stocking3093092023-08-15
G420333Compression Stocking3333332023-08-15
G420334Compression Stocking3343342023-08-15
G420335Compression Stocking3353352023-08-15
G420336Compression Stocking3363362023-08-15
G420337Compression Stocking3373372023-08-15
G420338Compression Stocking3383382023-08-15
G420339Compression Stocking3393392023-08-15
G420341Compression Stocking3413412023-08-15
G420342Compression Stocking3423422023-08-15
G420410Compression Stocking4104102023-08-15

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