Identity
- Trade Name
- COMPRESSION PADDLE FDA UDI
- Generic Name
- Radiological inflatable compression paddle FDA UDI
- Device Name
- Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons. The Paddle features a rubber compression bladder, easily inflated by means of a built-in baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression. FDA UDI
- Model / Reference
- 14107 FDA UDI
- Description
- Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons. The Paddle features a rubber compression bladder, easily inflated by means of a built-in baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843696114312 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Radiological inflatable compression paddle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological inflatable compression paddle
Compression Paddle by Flow X-Ray Corp. — 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
- Flow X-Ray Corp.
Sources (1)
- FDA UDI cb9f594d-4711-4707-b943-80cf233c9e62 33 fields · synced May 30, 2026