Identity
- Trade Name
- Single-Use Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis FDA UDI
- Model / Reference
- UA1335 FDA UDI
- Description
- Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916000806 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Single-Use Needle Guide by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Manufacturer
- Bk Medical ApS
Sources (1)
- FDA UDI 2a9a10f0-647c-49c1-9ec1-cd066e6d51e1 35 fields · synced May 30, 2026