FDA UDI
In Commercial Distribution
🇺🇸 United States
Seraket Tourniquets
DI: 70818087010824
·
Model: 22712000
·
PROPPER MANUFACTURING COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
120
Basic Information
- Brand Name
- Seraket Tourniquets
- Primary DI
- 70818087010824
- Version / Model
- 22712000
- Catalog Number
- 22712000
- Company Name
- PROPPER MANUFACTURING COMPANY, INC.
- Labeler DUNS
- 001483130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 120
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- 5a5d38eb-168f-4997-aaca-e30b1ea6626f
Device Description
Seraket Tourniquet - Case of 120
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 35844 | Limb tourniquet, manual, reusable | A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10818087010822 | GS1 | ||||
| Primary | 70818087010824 | GS1 |