Compreflex Pulse Calf SM T Black 3601-UC-BKT

GUDID 00745129331368

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 ID00745129331368
NIH Device Record Keye5c2bc5d-c6e1-4aa3-be80-83a36a8484b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompreflex Pulse Calf SM T Black
Version Model Number21739
Catalog Number3601-UC-BKT
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100745129331368 [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 Date2025-07-11
Device Publish Date2025-07-03

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