← Back to catalogue
InnoFine
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref DGCK-0101Model DGCK series; DGK series; NGB-024-DK, NGB-063-DK
Identity
- Trade Name
- General purpose biopsy kit (in-plane) EUDAMEDInnoFine FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Disposable Needle Guides Kit EUDAMEDDisposable Needle Guides Kit for general purpose biopsy(in-plane), contents: Needle guide(In-Plane) acceptable needle sizes:10/12/14/16/18/20/22G, 6F/8F/10F; 20g gel; 14x100cm TPU cover, rubber bands. FDA UDI
- Model / Reference
- DGCK-0101 EUDAMEDFDA UDIDGCK series; DGK series; NGB-024-DK, NGB-063-DK EUDAMED
- Description
- Disposable Needle Guides Kit for general purpose biopsy(in-plane), contents: Needle guide(In-Plane) acceptable needle sizes:10/12/14/16/18/20/22G, 6F/8F/10F; 20g gel; 14x100cm TPU cover, rubber bands. FDA UDI
Identifiers
- Catalog Number
- 11109 FDA UDI
- Primary DI / UDI-DI
- 06975122551096 EUDAMEDFDA UDI
- Basic UDI-DI
- 69715547206X4 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
Yes
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
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI b275d84a-33c7-472f-92ef-eb6ff8ea2f13 36 fields · synced Sep 18, 2026
- EUDAMED 8276c8c4-cb01-45a8-82e3-5066c21416ba 61 fields · synced Sep 18, 2026