FDA.reportPublic FDA data

WELLBRACE

Primary DI
07798094541143
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1203-305 U L
Device description
CORRECTOR DE POSTURA REGULABLE U L
Published
2024-01-05
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
false

Product Codes#

Code, Name table
CodeName
IPTOrthosis, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798094541143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798094541143077980945411437798094541143

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle orthosisA prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It is formed as a figure-of-eight harness that descends from the shoulders, passes under each arm and crosses over the back. It has broad, padded straps and may have extra padding inserted at the back. This device may also be used to improve the patient's posture. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
971365986
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798094540023WELLBRACE1601-AR U U2024-01-08
07798128673581WELLBRACE1215-ANR U L2024-02-29
07798094540160WELLBRACE1205-2400R U S2024-02-28
07798094540177WELLBRACE1205-2400R U M2024-02-28
07798094540184WELLBRACE1205-2400R U L2024-02-28
07798094540191WELLBRACE1205-2400R U XL2024-02-28
07798094540207WELLBRACE1205-2400R U 2XL2024-02-28
07798094540269WELLBRACE1205-2800R U S2024-02-28
07798094540276WELLBRACE1205-2800R U M2024-02-28
07798094540283WELLBRACE1205-2800R U L2024-02-28
07798094540290WELLBRACE1205-2800R U XL2024-02-28
07798094540306WELLBRACE1205-2800R U 2XL2024-02-28
07798094540313WELLBRACE1205-2800T U S2024-02-28
07798094540320WELLBRACE1205-2800T U M2024-02-28
07798094540337WELLBRACE1205-2800T U L2024-02-28
07798094540344WELLBRACE1205-2800T U XL2024-02-28
07798094540351WELLBRACE1205-2800T U 2XL2024-02-28
07798094540368WELLBRACE1205-3200R U S2024-02-28
07798094540924WELLBRACE1205-640 U S2024-02-28
07798094540931WELLBRACE1205-640 U M2024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113682716Tailback2-56Manamed, Inc.IPT2025-09-19
00810113682723Tailback2-64Manamed, Inc.IPT2025-09-19
04823097722114TM "Rehabilitimed" OT-1V Mp ComfortREABILITIMED TOVIPT2025-05-17
04823097722121TM "Rehabilitimed" OT-1V Lp ComfortREABILITIMED TOVIPT2025-05-17
04823097722138TM "Rehabilitimed" OT-1V S ComfortREABILITIMED TOVIPT2025-05-17
04823097722145TM "Rehabilitimed" OT-1V Sh ComfortREABILITIMED TOVIPT2025-05-17
04823097722152TM "Rehabilitimed" OT-1V M ComfortREABILITIMED TOVIPT2025-05-17
04823097722169TM "Rehabilitimed" OT-1V L ComfortREABILITIMED TOVIPT2025-05-17
04823097722176TM "Rehabilitimed" OT-1V XL ComfortREABILITIMED TOVIPT2025-05-17
04823097722183TM "Rehabilitimed" OT-1V Mp ComfortREABILITIMED TOVIPT2025-05-17
04823097722190TM "Rehabilitimed" OT-1V Lp ComfortREABILITIMED TOVIPT2025-05-17
04823097722206TM "Rehabilitimed" OT-1V S ComfortREABILITIMED TOVIPT2025-05-17
04823097722213TM "Rehabilitimed" OT-1V Sh ComfortREABILITIMED TOVIPT2025-05-17
04823097722220TM "Rehabilitimed" OT-1V M ComfortREABILITIMED TOVIPT2025-05-17
04823097722237TM "Rehabilitimed" OT-1V L ComfortREABILITIMED TOVIPT2025-05-17
04823097722244TM "Rehabilitimed" OT-1V XL ComfortREABILITIMED TOVIPT2025-05-17
04823097722329TM "Rehabilitimed" OT-1V-U Lp ComfortREABILITIMED TOVIPT2025-05-17
04823097722336TM "Rehabilitimed" OT-1V-U S ComfortREABILITIMED TOVIPT2025-05-17
04823097722343TM "Rehabilitimed" OT-1V-U M ComfortREABILITIMED TOVIPT2025-05-17
04823097722350TM "Rehabilitimed" OT-1V-U L ComfortREABILITIMED TOVIPT2025-05-17
04823097722367TM "Rehabilitimed" OT-1V-U XL ComfortREABILITIMED TOVIPT2025-05-17
04823097722374TM "Rehabilitimed" OT-1V-U Lp ComfortREABILITIMED TOVIPT2025-05-17
04823097722381TM "Rehabilitimed" OT-1V-U S ComfortREABILITIMED TOVIPT2025-05-17
04823097722398TM "Rehabilitimed" OT-1V-U M ComfortREABILITIMED TOVIPT2025-05-17
04823097722404TM "Rehabilitimed" OT-1V-U L ComfortREABILITIMED TOVIPT2025-05-17
04823097722411TM "Rehabilitimed" OT-1V-U XL ComfortREABILITIMED TOVIPT2025-05-17
04823097722473TM "Rehabilitimed" OT-1D-4 Sp ComfortREABILITIMED TOVIPT2025-05-17
04823097722480TM "Rehabilitimed" OT-1D-4 Mp ComfortREABILITIMED TOVIPT2025-05-17
04823097722497TM "Rehabilitimed" OT-1D-4 Lp ComfortREABILITIMED TOVIPT2025-05-17
04823097722503TM "Rehabilitimed" OT-1D-4 S ComfortREABILITIMED TOVIPT2025-05-17