Identity
- Trade Name
- Adaptable FDA UDI
- Generic Name
- Arm procedure positioner, reusable FDA UDI
- Device Name
- The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm. FDA UDI
- Model / Reference
- Adaptable Rail Extender FDA UDI
- Description
- The Rail Extender intended use is to make the Smith & Nephew T-Max Beach Chair compatible with the Enovis Adaptable Arm, by extending the Rail of the Back Side of the T-Max to install the Adaptable Arm, achieving a complete exposure and mobility on the patient arm. FDA UDI
Identifiers
- Catalog Number
- 804-33-006 FDA UDI
- Primary DI / UDI-DI
- 00860012987818 FDA UDI
- FDA Product Code
- BWN FDA UDI
- GMDN Term
- Arm procedure positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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: Arm procedure positioner, reusable
Adaptable by Quantum OPS Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Quantum OPS Inc.
Sources (1)
- FDA UDI ecabe90c-8a4a-457c-9a46-8d8c6aed1322 34 fields · synced Jun 9, 2026