FDA.report

PROFIT

Primary DI
07798128675554
Brand
PROFIT
Company
PANTYMED S.A.
Model
1101-MASD U XL
Device description
Air Sport free finger wristband - SIZE XL
Published
2024-02-01
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
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07798128675554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07798128675554077981286755547798128675554

GMDN Terms

TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. 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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