FDA.reportPublic FDA data

Hysynal

Primary DI
00087453143478
Brand
Hysynal
Company
HYGENIC CORPORATION, THE
Model
14347
Device description
"HYSYNAL 1"" TOURNIQUET STRAP 25/RL 100/CS"
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00087453143478PrimaryGS10
20087453143472Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00087453143478000874531434780874531434780087453143478
2008745314347220087453143472

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Width1Inch

Regulatory Flags#

DUNS number
004163390
Device count
1000
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087453001662Hygenic155832026-01-13
00087453001679Hygenic155842026-01-13
00087453127560TheraBand Kinesiology Tape127562025-03-11
00087453127577TheraBand Kinesiology Tape127572025-03-11
00087453127584TheraBand Kinesiology Tape127582025-03-11
00087453127409TheraBand Kinesiology Tape127402025-03-10
00087453127447TheraBand Kinesiology Tape127442025-03-10
00087453127454TheraBand Kinesiology Tape127452025-03-10
00087453127461TheraBand Kinesiology Tape127462025-03-10
00087453127478TheraBand Kinesiology Tape127472025-03-10
00087453127492TheraBand Kinesiology Tape127492025-03-10
20087453143472Hysynal143472025-03-10
00087453127393TheraBand Kinesiology Tape127392025-03-10
00087453127416TheraBand Kinesiology Tape127412025-03-10
00087453102048Hysynal102042019-04-08
00087453127515TheraBand Kinesiology Tape 127512019-02-08
00087453127522TheraBand Kinesiology Tape 127522019-02-08
00087453127539TheraBand Kinesiology Tape 127532019-02-08
00087453127546TheraBand Kinesiology Tape 127542019-02-08
00087453127553TheraBand Kinesiology Tape 127552019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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00630094049106Bioseal Inc.BIOSEALGAX2024-01-24
00630094049120Bioseal Inc.BIOSEALGAX2024-01-24
00630094049137Bioseal Inc.BIOSEALGAX2024-01-24
00630094049144Bioseal Inc.BIOSEALGAX2024-01-24
00630094049151Bioseal Inc.BIOSEALGAX2024-01-24
00630094490229Bioseal Inc.BIOSEALGAX2024-01-24