Identity
- Trade Name
- Neurgain FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- XYZ Manipulator FDA UDI
- Model / Reference
- NGN-9002 FDA UDI
- Description
- XYZ Manipulator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850059514016 FDA UDI
- FDA Product Code
- HAO FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4535 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Neurgain by Neurgain Technologies — 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
- II Ring Retractor — AUTOMATED MEDICAL PRODUCTS CORP. · Class I
- 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
- Neurgain Technologies
Sources (1)
- FDA UDI ef0150f5-4b07-4de6-828e-68ebfaf04df7 33 fields · synced May 31, 2026