FDA.report

12 MedaFit

Primary DI
00745129305789
Brand
12 MedaFit
Company
SIGVARIS INC
Model
12TH
Catalog number
1204-THR-R
Device description
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.
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MDRBinder, Medical, Therapeutic

Product Code Classifications

CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00745129305789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129305789007451293057897451293057890745129305789

GMDN Terms

TermDefinition
General-purpose medical foam padding, single-useA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags

DUNS number
189738719
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
07613378196171862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Black3206013206012026-03-19
07613378196188862N-CUSTOM ECF2 AG Quadrinova UNI °° Black3206003206002026-03-19
07613378196577862N-CUSTOM ECF2 AG Quadrinova UNI Black3205613205612026-03-19
07613378196959862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Caramel3205233205232026-03-19
07613378196966862N-CUSTOM ECF2 AG Quadrinova UNI °° Caramel3205223205222026-03-19
07613378197352862N-CUSTOM ECF2 AG Quadrinova UNI Caramel3204833204832026-03-19
07613378197734862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Grey3204453204452026-03-19
07613378197741862N-CUSTOM ECF2 AG Quadrinova UNI °° Grey3204443204442026-03-19
07613378198137862N-CUSTOM ECF2 AG Quadrinova UNI Grey3204053204052026-03-19
07613378198519862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Savanna3203673203672026-03-19
07613378198526862N-CUSTOM ECF2 AG Quadrinova UNI °° Savanna3203663203662026-03-19
07613378198915862N-CUSTOM ECF2 AG Quadrinova UNI Savanna3203273203272026-03-19
07613378199301862N-CUSTOM ECF2 AG Quadrinova UNI °° Skin3202883202882026-03-19
07613378199691862N-CUSTOM ECF2 AG Quadrinova UNI Skin3202493202492026-03-19
07613378277122862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Grey3554563554562026-03-19
07613378277139862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Caramel3554573554572026-03-19
07613378277146862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Skin3554583554582026-03-19
07613378277153862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Savanna3554593554592026-03-19
07613378277177862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Marine3554613554612026-03-19
07613378277184862N-CUSTOM ECF2 AG Micro knobbed band UNI Grey3554623554622026-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00636257043066MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043073MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043080MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043097MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043103MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043110MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043127MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043134MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043141MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043158MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043165MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043172MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043189MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043196MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043202MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043219MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047507MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047514MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047521MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047538MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047545MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047552MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047569MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047576MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047583MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047590MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00745129331610Cflex Reduce Full Leg SM SM SM Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331627Cflex Reduce Full Leg LG LG LG Tall Left BlackSIGVARIS INCMDR2025-08-15
00745129331634Cflex Reduce Full Leg LG LG LG Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331641Cflex Reduce Full Leg SM SM SM Reg Left BlackSIGVARIS INCMDR2025-08-15