Identity
- Trade Name
- Single-Use Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Single-use needle guide EUDAMEDSterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), each with 9 different inserts for 10-20 gauge needles FDA UDISterile packed. Includes: 4 free-angle in-plane inserts, 4 out-of-plane 4-channel inserts and 4 out-of-plane free-angle inserts for 14-22 gauge needles FDA UDI
- Model / Reference
- UA1338 EUDAMEDFDA UDIUA1345 FDA UDI
- Description
- Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), each with 9 different inserts for 10-20 gauge needles FDA UDISterile packed. Includes: 4 free-angle in-plane inserts, 4 out-of-plane 4-channel inserts and 4 out-of-plane free-angle inserts for 14-22 gauge needles FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916000868 EUDAMEDFDA UDI05704916000981 FDA UDI
- Basic UDI-DI
- 570491601101AJ EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11049099 VARIOUS ULTRASOUND INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Denmark 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
No
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
Single-Use Needle Guide by Bk Medical ApS — 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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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
- Manufacturer
- Bk Medical ApS
Sources (3)
- FDA UDI 0b4f8098-f081-41e5-b7ea-812cf03bd863 34 fields · synced Jul 9, 2026
- FDA UDI 00746bd7-b2c7-427a-b6da-8fa9e916ac55 34 fields · synced May 30, 2026
- EUDAMED 57de2b8a-eaf2-470d-bd9a-d8753388e867 61 fields · synced Jul 9, 2026