FDA.reportPublic FDA data

Tourni-Cot - Extra Large

Primary DI
00855364004061
Brand
Tourni-Cot - Extra Large
Company
MAR-MED INC.
Model
TXL
Device description
Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes.
Published
2020-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853472000FINGER TOURNIQUETTEJoseph B. Marogil1985-10-10GAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855364004068PackageGS120In Commercial Distribution
00855364004061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085536400406810855364004068
00855364004061008553640040618553640040610855364004061

GMDN Terms#

Term, Definition table
TermDefinition
Digit tourniquet, manualAn elastic ring designed to be applied to an injured digit (finger or toe) to provide immediate haemostasis and subsequent wound visualization. The elastic properties of the device enable it to automatically adjust to the size of the digit to which it is applied and to provide pressure to stem the flow of blood producing a bloodless field for emergent and elective procedures. It is typically used in emergency departments, operating rooms (OR) for finger/toe surgery, by first responders [medical centres and emergency medical services (EMS)], and in environments where sharp utensils are used (e.g., restaurants, butcher shops). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
616-454-3000info@marmed.com

Regulatory Flags#

DUNS number
176664068
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855364004146ZeroWetSuperShieldSS-100NS2025-05-15
00855364004153ZeroWetKlenzalacKL-10NS2025-05-15
00855364004115Rhino-Pak 45mmRP-452025-02-06
00855364004139Rhino-Pak 75mmRP-752025-02-06
10855364004112Rhino-Pak 45mmRP-452025-02-06
00855364004122Rhino-Pak 55mmRP-552025-02-06
10855364004136Rhino-Pak 75mmRP-752025-02-06
00855364004030Tourni-Cot - SmallTCS2020-09-23
00855364004047Tourni-Cot - MediumTCM2020-09-23
00855364004054Tourni-Cot - LargeTCL2020-09-23
00855364004085Tourni-Cot - UniversalTCU2020-09-23
00855364004108Derma-StentDMT2020-09-23
00855364004092Balloon ExtractorBEX2020-09-23
10855364004037Tourni-Cot - SmallTCS2020-09-23
10855364004068Tourni-Cot - Extra LargeTXL2020-09-23
10855364004099Balloon ExtractorBEX2020-09-23
10855364004105Derma-StentDMT2020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00630094049151Bioseal Inc.BIOSEALGAX2024-01-24