Compreflex Contain TC SM Reg LT Black 3401-TCR-L

GUDID 00745129328276

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.

SIGVARIS INC

General-purpose medical foam padding, single-use
Primary Device ID00745129328276
NIH Device Record Keye7b30292-11a5-464a-85d1-f71835b47e97
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompreflex Contain TC SM Reg LT Black
Version Model Number34TC
Catalog Number3401-TCR-L
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 Datefalse
Expiration Datetrue
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
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100745129328276 [Primary]

FDA Product Code

MDRBinder, Medical, Therapeutic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-02
Device Publish Date2024-08-23

Devices Manufactured by SIGVARIS INC

00745129330040 - 832C Style Pattern 20-30mmHg M LL StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330057 - 832C Style Pattern 20-30mmHg M LS StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330064 - 832C Style Pattern 20-30mmHg M ML StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330071 - 832C Style Pattern 20-30mmHg M MS StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330088 - 832C Style Pattern 20-30mmHg M SL StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330095 - 832C Style Pattern 20-30mmHg M SS StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330101 - 832C Style Pattern 20-30mmHg W LL StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
00745129330118 - 832C Style Pattern 20-30mmHg W LS StormBluConfetti2025-07-01 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u

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