FDA.reportPublic FDA data

HidraWear

Primary DI
05391535510313
Brand
HidraWear
Company
HIDRAMED SOLUTIONS LIMITED
Model
GBB001-04
Device description
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care.Size: Extra Large
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDRBinder, Medical, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391535510313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391535510313053915355103135391535510313

GMDN Terms#

Term, Definition table
TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+3530873361512info@hidrawear.com

Regulatory Flags#

DUNS number
985651636
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391535510184HidraWearGAX002-012022-12-20
05391535510191HidraWearGAX002-022022-12-20
05391535510207HidraWearGAX002-032022-12-20
05391535510214HidraWearGAX002-042022-12-20
05391535510221HidraWearGAX002-052022-12-20
05391535510283HidraWearGBB001-012022-12-20
05391535510290HidraWearGBB001-022022-12-20
05391535510306HidraWearGBB001-032022-12-20
05391535510320HidraWearGBB001-052022-12-20
05391535510382HidraWearGBB002-012022-12-20
05391535510399HidraWearGBB002-022022-12-20
05391535510405HidraWearGBB002-032022-12-20
05391535510412HidraWearGBB002-042022-12-20
05391535510429HidraWearGBB002-052022-12-20
05391535510009HidraWearGAX001-012022-11-29
05391535510016HidraWearGAX001-022022-11-29
05391535510023HidraWearGAX001-032022-11-29
05391535510030HidraWearGAX001-042022-11-29
05391535510092HidraWearGAX001-052022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00745129335076Envelo Arm Wrap Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335083Envelo Arm Wrap Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335090Envelo Arm Wrap Max Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335120Envelo Arm Wrap Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335137Envelo Arm Wrap Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335144Envelo Arm Wrap Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335182Envelo Arm Wrap Large Short BeigeSIGVARIS INCMDR2026-07-22
00745129334918Envelo Arm Wrap Max Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334925Envelo Arm Wrap Max Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334932Envelo Arm Wrap Max Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334949Envelo Arm Wrap X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334956Envelo Arm Wrap X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334963Envelo Arm Wrap X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334970Envelo Arm Wrap Max X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334987Envelo Arm Wrap Max X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334994Envelo Arm Wrap Max X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335007Envelo Arm Wrap XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335014Envelo Arm Wrap XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335021Envelo Arm Wrap XX-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335038Envelo Arm Wrap Max XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335045Envelo Arm Wrap Max XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335052Envelo Arm Wrap Max XX-Large Long BlackSIGVARIS INCMDR2026-07-20
08300496073246SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073253SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15