832C Style Pattern 20-30mmHg W ML GraphiteConfetti 832CMLW06

GUDID 00745129319199

A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.

SIGVARIS INC

Compression/pressure sock/stocking, single-use
Primary Device ID00745129319199
NIH Device Record Key30cc499e-2625-4ed2-9eec-35917105c256
Commercial Distribution StatusIn Commercial Distribution
Brand Name832C Style Pattern 20-30mmHg W ML GraphiteConfetti
Version Model Number832C or 20522
Catalog Number832CMLW06
Company DUNS189738719
Company NameSIGVARIS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100745129319199 [Primary]

FDA Product Code

FQLStocking, Medical Support (For General Medical Purposes)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-16
Device Publish Date2025-06-06

Devices Manufactured by SIGVARIS INC

00745129319113 - 832C Style Pattern 20-30mmHg M LL GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319120 - 832C Style Pattern 20-30mmHg M LS GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319137 - 832C Style Pattern 20-30mmHg M ML GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319144 - 832C Style Pattern 20-30mmHg M MS GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319151 - 832C Style Pattern 20-30mmHg M SL GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319168 - 832C Style Pattern 20-30mmHg M SS GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319175 - 832C Style Pattern 20-30mmHg W LL GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129319182 - 832C Style Pattern 20-30mmHg W LS GraphiteConfetti2025-06-16 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.