Identity
- Trade Name
- Reison FDA UDI
- Generic Name
- Custom-made cushion FDA UDI
- Device Name
- Cushion for armboard, concave FDA UDI
- Model / Reference
- Cushion for armboard, concave FDA UDI
- Description
- Cushion for armboard, concave FDA UDI
Identifiers
- Catalog Number
- 514-100382 FDA UDI
- Primary DI / UDI-DI
- 07332339221584 FDA UDI
- FDA Product Code
- LGX FDA UDI
- GMDN Term
- Custom-made cushion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made cushion
Reison by Stille AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made cushion.
- Cushion — Reison Medical AB · Class I
- Cushion — Reison Medical AB · Class I
- Cushion — Reison Medical AB · Class I
- Empelvic — OWEN MUMFORD USA INCORPORATED · Class I
- Spectrum, Inc. — Spectrum Co. · Class I
- Cushion — Reison Medical AB · Class I
- Cushion — Reison Medical AB · Class I
- Wonderflex 3mm Unlined Silicone Sheet — SILIPOS Holding LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stille AB
Sources (1)
- FDA UDI 8beb4c47-0d38-4368-9f52-93b909dad08e 34 fields · synced May 30, 2026