FDA.reportPublic FDA data

Compression Stocking

Primary DI
G420401
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
401
Catalog number
401
Device description
Glove to Wrist
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
G420401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. 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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