FDA.report

Wavy Donning Gloves

Primary DI
00745129184339
Brand
Wavy Donning Gloves
Company
SIGVARIS INC
Model
590R
Catalog number
590RPRS
Device description
A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garments without causing damage to the stocking (e.g. from nails, jewelry). This device will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
Published
2016-12-05
Public version status
Update
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
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications

CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00745129184339PackageGS112In Commercial Distribution
00745129215309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129184339007451291843397451291843390745129184339
00745129215309007451292153097451292153090745129215309

GMDN Terms

TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for a hospitalized patient. 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
00636257211281MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211298MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211304MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211311MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211328MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211335MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211342MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211359MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211366MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211373MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211380MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211397MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211403MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211410MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211427MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211434MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211441MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211458MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211465MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211472MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211489MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211496MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211502MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211519MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257206751MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206768MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206775MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206782MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206799MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206805MEDIMEDI MANUFACTURING, INC.DWL2026-03-06