FDA.reportPublic FDA data

HemaClear

Primary DI
07290012685286
Brand
HemaClear
Company
ONEG HAKARMEL LTD
Model
Black Sterile Single Unit
Catalog number
SAH-090-BW-01A
Device description
All in One Surgical Tourniquet for Limb Surgery
Published
2024-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
07290012685088PackageGS110In Commercial Distribution
07290012685286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012685088072900126850887290012685088
07290012685286072900126852867290012685286

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.

Regulatory Flags#

DUNS number
534017256
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012685460HemaClearHemaClear XL (double sleeve)PRH090BG02A2025-09-29
07290012685484HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685477HemaClearHemaClear XL (double sleeve)PRH090BW02A2025-09-29
07290012685491HemaClearHemaClear Long PinkPRH028PI02A2025-09-29
07290012685187Hema-THema-T - Single UnitSAHS-30-80-T2025-02-03
07290012685415HemaClearHemaClear XXL - Single unitSAH-099-TU-01A2025-02-03
07290012685439HemaShockHemaShock EMS - Single UnitSAHS-EM-SN-01A2025-02-03
07290012685446HemaShockHemaShock Upper Extremity - Single unitPRHS-UE-SN-01A2025-02-03
07290012685453Hema-THema-T - Single UnitSAHS-30-80-T2025-02-03
07290012685422HemaClearHemaClear XXL - Single unitSAH-099-TU-01A2025-02-03
07290012685156HemaShockHemaShock EMS - Single UnitSAHS-EM-SN-01A2025-02-03
07290012685163HemaShockHemaShock Upper Extremity - Single unitPRHS-UE-SN-01A2025-02-03
07290012685217HemaClearPink Sterile Single UnitSAH028-PI-01A2024-08-24
07290012685224HemaClearGreen Sterile Single UnitSAH040-GR-01A2024-08-24
07290012685231HemaClearRed Sterile Single UnitSAH040-RE-01A2024-08-24
07290012685248HemaClearYellow Sterile Single UnitSAH040-YE-01A2024-08-24
07290012685255HemaClearBlue Sterile Single UnitSAH060-BL-01A2024-08-24
07290012685262HemaClearBrown Sterile Single UnitSAH060-BR-01A2024-08-24
07290012685279HemaClearOrange Sterile Single UnitSAH060-OR-01A2024-08-24
07290012685293HemaClearModel A (F&A) Sterile Single UnitSAH-032-MA-01A2024-08-24

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Primary DI, Brand, Company table
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30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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