Sterile Disposable Endocavity Needle Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- aspen surgical® EUDAMEDSterile Disposable Endocavity Needle Guide FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Needle Guides (sterile) EUDAMED
- Model / Reference
- 1-535-5178 EUDAMED5178 FDA UDI
Identifiers
- Catalog Number
- 5178 FDA UDI
- Primary DI / UDI-DI
- 00841912101702 EUDAMEDFDA UDI
- Basic UDI-DI
- 084191215000STNE EUDAMED
- FDA Product Code
- KKX FDA UDIITX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI892.1570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Needle guide, single-useBody-orifice ultrasound imaging transducer cover, basic
Sterile Disposable Endocavity Needle Guide by Protek Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (2)
- FDA UDI 8873997f-8e70-49e7-951d-3663edc08d77 33 fields · synced Oct 7, 2026
- EUDAMED 33a7ad83-0c77-4fb3-b8e7-79f88d76f5fd 61 fields · synced Oct 7, 2026