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SPY-PHI Articulating Arm, Imaging Head Holder
EUDAMEDFDA UDIClass I (EU MDR)
Ref HH1003Model AA-0100
Identity
- Trade Name
- SPY-PHI Articulating Arm, Imaging Head Holder EUDAMEDSPY-PHI System FDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- Atlas™ Rigid Arm, Single, 400mm, L-Column, Quick Connect- Square EUDAMEDSPY-PHI Articulating Arm, Imaging Head Holder FDA UDI
- Model / Reference
- AA-0100 EUDAMEDHH1003 EUDAMEDFDA UDI
- Description
- SPY-PHI Articulating Arm, Imaging Head Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810007560021 EUDAMEDFDA UDI
- Basic UDI-DI
- 81000756AXS00016J EUDAMED
- Direct Marketing DI
- 00810007560021 EUDAMED
- FDA Product Code
- FXR FDA UDI
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
SPY-PHI Articulating Arm, Imaging Head Holder by Axcess Surgical Innovations LLC. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 81000756AXS00016J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Axcess Surgical Innovations LLC.
- EUDAMED SRN
- US-MF-000014666
- Authorised Representative
- Axcess Surgical Innovations B.V. NL-AR-000002697
Sources (2)
- EUDAMED c6f52855-4cd3-4a66-8036-5f7ff9eeead5 61 fields · synced Jun 19, 2026
- FDA UDI 42e04844-4870-4db7-a0b2-8fd5c151de42 33 fields · synced May 30, 2026