Identity
- Trade Name
- Hayden Medical FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Detachable Locking Scope Holder (3mm to 12.7mm diameter) for Martin's Arm Stand, hex fitting with plastic Delrin holder FDA UDI
- Model / Reference
- 115-305QC FDA UDI
- Description
- Detachable Locking Scope Holder (3mm to 12.7mm diameter) for Martin's Arm Stand, hex fitting with plastic Delrin holder FDA UDI
Identifiers
- Catalog Number
- 115-305QC FDA UDI
- Primary DI / UDI-DI
- 00840319719800 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Hayden Medical by Hayden Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Flexarm Surgical Holders and Positioners — FLEXBAR MACHINE CORP. · Class I
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- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · Class II
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
- Hayden Medical Inc
Sources (1)
- FDA UDI 2ede11cd-09d7-4044-8753-b78c476c2daa 35 fields · synced Jun 1, 2026