FDA.reportPublic FDA data

MAGNET SHEET SQUARE 9X5MM

Primary DI
14897076722560
Brand
MAGNET SHEET SQUARE 9X5MM
Company
TENS PLUS INDUSTRIAL COMPANY
Model
"Multi.Card "
Published
2022-11-14
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
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897076722560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489707672256014897076722560

GMDN Terms#

Term, Definition table
TermDefinition
Static magnetic massagerA hand-held device designed to be moved over body surfaces that uses static magnets (e.g., rotating magnetic balls) intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
663211978
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
14897076721457Lion.Warm.XLGY53362023-06-05
14897076721655Multi.D.1.5MD28022023-06-05
14897076721815Moxa.Bx.BamSGY53372023-06-05
14897076721822Moxa.Bx.BamLGY53382023-06-05
14897076721853PistolDY09502023-06-05
14897076721860Pistol.LongDY21112023-06-05
14897076721877Ins.MP.SMD26112023-06-05
14897076721884Ins.MP.MMD26122023-06-05
14897076721891Ins.MP.LMD26132023-06-05
14897076722263Guasha.SBY26082023-06-05
14897076722270Guasha.MBY26092023-06-05
14897076722287Guasha.LBY26102023-06-05
14897076722454Tiger.Warm.SGY53672023-06-05
14897076722546Tiger.Warm.SGY53672023-06-05
14897076722577Bio.N.2MD28632023-06-05
14897076722614Ring.FingerMY26022023-06-05
14897076722621Tsubo.VibMY27502023-06-05
14897076722843Probe with rollerBY23472023-06-05
14897076720214Tsun.MeterBD23612023-05-15
14897076722645"Pump.Sq.Sm "WY49632023-05-15

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