FDA UDI
In Commercial Distribution
🇺🇸 United States
Susol® Digital Tourniquets Large Blue (Pack of 50)
DI: 05060418834845
·
Model: S-TQL
·
BAILEY INSTRUMENTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Susol® Digital Tourniquets Large Blue (Pack of 50)
- Primary DI
- 05060418834845
- Version / Model
- S-TQL
- Company Name
- BAILEY INSTRUMENTS LTD
- Labeler DUNS
- 769260357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-23
- Public Version
- 1
- Public Version Date
- 2024-01-31
- Public Version Status
- New
- Public Device Record Key
- af4c1f33-cca6-4d0a-ba94-6aa5fa81c9c2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 | 05060418834845 | GS1 | ||||
| Package | 05060418833527 | GS1 | Pack | 50 | In Commercial Distribution |