FDA.reportPublic FDA data

T-RING FLEX Digit Tourniquet

Primary DI
00869193000057
Brand
T-RING FLEX Digit Tourniquet
Company
PRECISION MEDICAL DEVICES, LLC
Model
TR002
Device description
The T-RING FLEX is a non-pneumatic tourniquet for digits (fingers and toes). It is one size fits all, and automatically adjusts to the size of the digit to apply a safe and effective pressure (approximately 150 mm Hg). It is completely flexible and fits nicely in small spaces; i.e. pediatric fingers and toes.
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869193000057PrimaryGS10
00869193000040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869193000057008691930000578691930000570869193000057
00869193000040008691930000408691930000400869193000040

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
3027782335wgreen@thetring.com

Regulatory Flags#

DUNS number
786846571
Device count
25
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869193000088Topica Laceration Closure TrayTLC 0012025-06-14
00869193000002T-STRIPTS-0012025-06-13
00869193000071Topica Laceration Closure TrayTLC 0012025-06-14
00869193000040T-RING FLEX Digit TourniquetTR0022025-06-11
10869193000016T-RING Digit TourniquetTR0012025-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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