FDA.reportPublic FDA data

TOURNIK-IT

Primary DI
08057592700032
Brand
TOURNIK-IT
Company
FLAMOR SRL
Model
TK-01
Device description
TOURNIK-IT It’s a hemostasis system used to control bleeding
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08057592700032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057592700032080575927000328057592700032

GMDN Terms#

Term, Definition table
TermDefinition
Venous tourniquet, reusableA device in the form of a narrow strap intended to be wrapped and manually tightened typically around a patient's arm to control/stop blood flow during collection of blood from a vein; it may additionally be used with a pressure bandage to apply pressure to a wound. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness; it is not fastened via a rotating handle mechanism (i.e., not a windlass). This is a reusable device which might be intended for single-patient use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629852208
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057592700025TOURNIK-ITTK-002025-05-28
08057592700049TOURNIK-ITTK-02T2025-05-28
08057592700070HYBRIBOARDEMS2025-05-23
08057592700087HYBRIBOARDSPORT2025-05-23
08057592700094NECKLITEBLUE2025-01-27
08057592700100NECKLITEBLUE / SC2025-01-27
08057592700117NECKLITEYLW 2025-01-27
08057592700124NECKLITEYLW / SC2025-01-27
08057592700131NECKLITEBLK2025-01-27
08057592700148NECKLITEBLK / SC2025-01-27

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
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
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
00630094049182Bioseal Inc.BIOSEALGAX2024-01-25
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00630094049069Bioseal Inc.BIOSEALGAX2024-01-24
00630094049076Bioseal Inc.BIOSEALGAX2024-01-24
00630094049083Bioseal Inc.BIOSEALGAX2024-01-24
00630094049090Bioseal Inc.BIOSEALGAX2024-01-24
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