FDA UDI
In Commercial Distribution
🇺🇸 United States
Tech-Med
DI: 10665973022489
·
Model: 4418
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Tech-Med
- Primary DI
- 10665973022489
- Version / Model
- 4418
- Catalog Number
- 4418
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 2
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- f6ac046b-df9d-4039-ac93-dc66c1f23f45
Device Description
LF Tourniquet, Push Button
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 67045 | Emergency tourniquet, manual, reusable | A device in the form of a strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening bleeding (e.g., in a military setting and/or high-risk work environment); it may additionally be used for non-life-threatening injuries. It typically has a fastening/locking mechanism with a rotating handle (windlass) that allows a tight grip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20665973022486 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 10665973022489 | GS1 | ||||
| Unit of Use | 00665973022482 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]