Identity
- Trade Name
- Norton Arm Restraint FDA UDI
- Generic Name
- Arm procedure positioner, single-use FDA UDI
- Device Name
- Intended to support and maintain the position of an anesthetized patient during surgery FDA UDI
- Model / Reference
- 711400 FDA UDI
- Description
- Intended to support and maintain the position of an anesthetized patient during surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113230686 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Arm procedure positioner, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arm procedure positioner, single-use
Norton Arm Restraint by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arm procedure positioner, single-use.
- Halyard — O&M HALYARD, INC. · Class I
- Sharn Inc — Sharn Anesthesia · Class I
- Halyard — O&M HALYARD, INC. · Class I
- Sharn Inc — Sharn Anesthesia · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- Halyard — O&M HALYARD, INC. · Class I
- Halyard — O&M HALYARD, INC. · Class I
- Halyard — O&M HALYARD, INC. · 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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI 39d60638-6456-4c56-b430-1967d487518d 34 fields · synced Jun 9, 2026