Compression Stocking

Primary DI
G420335
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
335
Catalog number
335
Device description
Waist One Stump Panty Closed
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)

Product Code Classifications#

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

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
G420335PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. 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
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
G420412Compression Stocking4124122023-08-15

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