FDA.reportPublic FDA data

Tournisec

Primary DI
00199874723976
Brand
Tournisec
Company
62K SOLUTIONS, LLC
Model
KFG108
Device description
"10 Pack - Disposable, non-sterile, single use, form fitting, stockinette worn by patient that acts as padding and method of securing a pneumatic tourniquet at the thigh. Regular size. Width 8"". Waist size < or = 35""."
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILGStocking, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILGStocking, ElasticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199874723976PrimaryGS10
10199874682409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199874723976001998747239761998747239760199874723976
1019987468240910199874682409

GMDN Terms#

Term, Definition table
TermDefinition
Tubular support bandage, non-latex, single-useA tubular elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width8Inch

Contacts#

Phone, Email table
PhoneEmail
9788917836customerservice@tournisec.com

Regulatory Flags#

DUNS number
129718808
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199874682402TournisecKFG1122025-12-15
10199874723973TournisecKFG1122025-12-15
10199874682409TournisecKFG1082025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874682402Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874723973Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874682409Tournisec62K SOLUTIONS, LLCILG2025-12-15
00818323021783ViveVIVE HEALTH LLCILG2024-09-06
00818323021790ViveVIVE HEALTH LLCILG2024-09-06
10818323021780ViveVIVE HEALTH LLCILG2024-09-06
10818323021797ViveVIVE HEALTH LLCILG2024-09-06
10850053289382SURGYCOSurgyco LLCILG2023-12-15
10850053289399SURGYCOSurgyco LLCILG2023-12-15
10850053289405SURGYCOSurgyco LLCILG2023-12-15
10850053289412SURGYCOSurgyco LLCILG2023-12-15
00850053289385SURGYCOSurgyco LLCILG2023-12-15
00850053289392SURGYCOSurgyco LLCILG2023-12-15
00850053289408SURGYCOSurgyco LLCILG2023-12-15
00850053289415SURGYCOSurgyco LLCILG2023-12-15
00810113570488ViveVIVE HEALTH LLCILG2023-08-23
10810113570485ViveVIVE HEALTH LLCILG2023-08-23
00810113570747ViveVIVE HEALTH LLCILG2022-11-28
10810113570744ViveVIVE HEALTH LLCILG2022-11-28
00818323023503Vive VIVE HEALTH LLCILG2022-10-03
00818323023510Vive VIVE HEALTH LLCILG2022-10-03
10818323023500Vive VIVE HEALTH LLCILG2022-10-03
10818323023517Vive VIVE HEALTH LLCILG2022-10-03
10192253062434CONVERTORSCardinal Health 200, LLCILG2022-09-12
50192253062432CONVERTORSCardinal Health 200, LLCILG2022-09-12
00373317568212AUMSlv Pharmaceuticals LLCILG2022-03-08
00636257031308MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031315MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031322MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031339MEDIMEDI MANUFACTURING, INC.ILG2021-09-07