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InnoFine
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10529Model DGC series; DG series; DT series; NGB-xxx-D series
Identity
- Trade Name
- General purpose needle guides (in-plane) EUDAMEDInnoFine FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Disposable Needle Guides EUDAMEDDisposable Needle Guides for general purpose biopsy(in-plane) ,acceptable needle sizes:10/12/14/16/18/20/22G, 6F/8F/10F, used with various kinds of reusable brackets and corresponding ultrasound transducers. FDA UDI
- Model / Reference
- DGC series; DG series; DT series; NGB-xxx-D series EUDAMED10529 EUDAMEDDGC-0101 FDA UDI
- Description
- Disposable Needle Guides for general purpose biopsy(in-plane) ,acceptable needle sizes:10/12/14/16/18/20/22G, 6F/8F/10F, used with various kinds of reusable brackets and corresponding ultrasound transducers. FDA UDI
Identifiers
- Catalog Number
- 10529 FDA UDI
- Primary DI / UDI-DI
- 06971554725296 EUDAMEDFDA UDI
- Basic UDI-DI
- 69715547204WY EUDAMED
- FDA Product Code
- OIJ FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, single-use
InnoFine by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
Sources (2)
- FDA UDI 54cf781b-3f2b-47e6-9021-c32263b801bc 36 fields · synced Jul 9, 2026
- EUDAMED c616acaa-c3f5-46a6-b202-747e5df2b098 61 fields · synced Jul 9, 2026