Identity
- Trade Name
- aspen surgical® EUDAMEDMulti-Angle Biopsy Starter Kit FDA UDIBard-parker Conventional Surgical Blade Handle Size 9 FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDIScalpel handle, reusable FDA UDI
- Device Name
- Needle Guides (sterile) EUDAMEDMulti Angle Biopsy Starter Kit for GE C1-5-D & C1-5-RS Ultrasound Transducers FDA UDIIntended to be used with surgical blades for tissue separation and other procedures that require a sharp surgical FDA UDI
- Model / Reference
- 1-535-7308 EUDAMED7308 FDA UDI371090 FDA UDI
- Description
- Multi Angle Biopsy Starter Kit for GE C1-5-D & C1-5-RS Ultrasound Transducers FDA UDIIntended to be used with surgical blades for tissue separation and other procedures that require a sharp surgical FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841912105069 EUDAMEDFDA UDI00840113202348 FDA UDI
- Basic UDI-DI
- 084191215000STNE EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDIScalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
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
Yes
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-useUltrasound imaging system tracking positioner, reusableBody-surface ultrasound imaging transducer cover
Multi-Angle Biopsy Starter Kit by Protek Medical Products, Inc. — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (3)
- FDA UDI cc26ef06-ec18-4903-8926-149bc09989ce 33 fields · synced Aug 1, 2026
- FDA UDI 8da4f28d-98e3-4771-965f-6b3de5497fa3 34 fields · synced May 29, 2026
- EUDAMED ff6cdc96-e78a-4ea9-9e55-200e62d4a84b 61 fields · synced Aug 1, 2026