FDA.reportPublic FDA data

HealX

Primary DI
00627987231120
Brand
HealX
Company
Swift Medical Inc
Model
1
Published
2019-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627987231120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627987231120006279872311206279872311200627987231120

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking stickerA hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202686960
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627987231168Sheeted HealX12024-09-10
00627987231151Ray 1SV4032022-04-18
00627987231144Swift VisionSV4032021-03-15
00627987231090Swift Skin and Wound S12019-10-04
00627987231106PointClickCare Skin and WoundS22019-10-04
00627987231113Healogics Photo+S32019-10-04
00627987231137Medline NE1® WMSS42019-10-04

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Primary DI, Brand, Company table
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00849987002702SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002733SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003037SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003044SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
00850085914002IMRISeyeIMRIS Imaging, Inc.FTY2026-05-07
G4250010My MedicalMy Medical Store LLCFTY2026-05-04
G4250020My MedicalMy Medical Store LLCFTY2026-05-04
00190776418724MillenniumAvalign Technologies, Inc.FTY2026-04-09
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00840117349827Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
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03662663108027Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
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03662663108065Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
03662663108096Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06
00371347019841Advance Dental ProductsThe Atlanta Dental Supply CompanyFTY2025-10-02
10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28