FDA.reportPublic FDA data

Compression Stocking

Primary DI
G420412
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
412
Catalog number
412
Device description
Vest with Sleeves
Published
2023-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
G420412PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, girdle, 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. Designed to be worn around the hips and/or shoulders, it is neither a strip/roll binder, limb sleeve, glove, nor sock. It is not intended to come into direct contact with, or to manage/treat, open wounds, injured skin, or infectious or infection-susceptible skin conditions. This is a reusable device.

Regulatory Flags#

DUNS number
038706180
Device count
1
DM exempt
false
Premarket exempt
false
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
G420021Compression Stocking0210212023-08-15
G420022Compression Stocking0220222023-08-15
G420101Compression Stocking1012023-08-15
G420102Compression Stocking1021022023-08-15
G420103Compression Stocking1031032023-08-15
G420104Compression Stocking1041042023-08-15
G420106Compression Stocking1061062023-08-15
G420201Compression Stocking2012012023-08-15
G420202Compression Stocking2022022023-08-15
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
G420331Compression Stocking3313312023-08-15

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