FDA.report

WELLBRACE

Primary DI
07798094541310
Brand
WELLBRACE
Company
PANTYMED S.A.
Model
1101-6000 U U
Device description
INMOVILIZADOR DE MUNECA- WELLB - UNICO
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

Related Records

Product Codes

CodeName
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07798094541310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07798094541310077980945413107798094541310

GMDN Terms

TermDefinition
Wrist immobilizer, reusableA rigid support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a reusable device.

Sterilization Methods

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 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

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