FDA.reportPublic FDA data

Compression Stocking

Primary DI
G420104
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
104
Catalog number
104
Device description
Arm Sleeve with Gauntlet and Shoulder Flap
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
G420104PrimaryHIBCC0

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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