Identity
- Trade Name
- Herc Flex 360 Universal Stabilizer Arm FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Model / Reference
- T401162 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00699753450943 FDA UDI
- FDA Product Code
- MWS FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Herc Flex 360 Universal Stabilizer Arm by Terumo Cardiovascular Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument assist arm system, manually-adjusted.
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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
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI aef09915-a703-48f6-8e09-cbd45990e46e 32 fields · synced Jun 9, 2026