FDA UDI
In Commercial Distribution
🇺🇸 United States
T-RING Digit Tourniquet
DI: 10869193000016
·
Model: TR001
·
PRECISION MEDICAL DEVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- T-RING Digit Tourniquet
- Primary DI
- 10869193000016
- Version / Model
- TR001
- Company Name
- PRECISION MEDICAL DEVICES, LLC
- Labeler DUNS
- 786846571
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-06-10
- Public Version
- 1
- Public Version Date
- 2025-06-18
- Public Version Status
- New
- Public Device Record Key
- c2076d18-6fc2-4e28-bda2-b8742dba1131
Device Description
The T-RING 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)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57827 | Digit tourniquet, manual | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10869193000016 | GS1 | ||||
| Unit of Use | 00869193000019 | GS1 |
Customer Contacts
- Phone
- 3027782335
- [email protected]