Identity
- Trade Name
- PTS Roll Stand with Basket FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- The PTS Roll Stand is a strong and sturdy mobile stand for use in a wide range of healthcare and clinical environments, including rehabilitation clinics and training rooms. Designed to securely hold up to two separate PTS for BFR instruments, plus accessories. FDA UDI
- Model / Reference
- 9-2200-550 FDA UDI
- Description
- The PTS Roll Stand is a strong and sturdy mobile stand for use in a wide range of healthcare and clinical environments, including rehabilitation clinics and training rooms. Designed to securely hold up to two separate PTS for BFR instruments, plus accessories. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M995922005501 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Surgical pneumatic tourniquet system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PTS Roll Stand with Basket by Delfi Medical Innovations Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc
Sources (1)
- FDA UDI 5b06d7b8-0ee7-4d89-97b7-c389d5bee30c 35 fields · synced Jun 1, 2026