FDA.reportPublic FDA data

5055 Custom Bandaging Kit

Primary DI
00745129328160
Brand
5055 Custom Bandaging Kit
Company
SIGVARIS INC
Model
5055-MV
Catalog number
5055-MV
Device description
Medical Vein - Custom Bandaging Kit with nonwoven padding and 3 rolls of inelastic compression bandages made without natural latex rubber
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745129328160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129328160007451293281607451293281600745129328160

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze roll/sheetA device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width4Inch
Width6.8Centimeter
Width10Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags#

DUNS number
189738719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745129335069Envelo Arm Wrap Small Short Beige3111-ARS or 221093111-ARS2026-07-22
00745129335076Envelo Arm Wrap Small Regular Beige3111-ARR or 221103111-ARR2026-07-22
00745129335083Envelo Arm Wrap Small Long Beige3111-ARL or 221113111-ARL2026-07-22
00745129335090Envelo Arm Wrap Max Small Short Beige3111-AMS or 221123111-AMS2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular Beige3111-AMR or 221133111-AMR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long Beige3111-AML or 221143111-AML2026-07-22
00745129335120Envelo Arm Wrap Medium Short Beige3112-ARS or 221153112-ARS2026-07-22
00745129335137Envelo Arm Wrap Medium Regular Beige3112-ARR or 221163112-ARR2026-07-22
00745129335144Envelo Arm Wrap Medium Long Beige3112-ARL or 221173112-ARL2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short Beige3112-AMS or 221183112-AMS2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular Beige3112-AMR or 221193112-AMR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long Beige3112-AML or 221203112-AML2026-07-22
00745129335182Envelo Arm Wrap Large Short Beige3113-ARS or 221213113-ARS2026-07-22
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° Black3206063206062026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN Black3205663205662026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° Caramel3205273205272026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN Caramel3204883204882026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° Grey3204493204492026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN Grey3204103204102026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° Savanna3203713203712026-07-22

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