Identity
- Trade Name
- Non-implantable, needle guide, reusable FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Reusable Needle Guide FDA UDI
- Model / Reference
- UA1282 FDA UDI
- Description
- Reusable Needle Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916001513 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Category: Needle guide, reusable
Non-implantable, needle guide, reusable by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, reusable.
- Redon guide needle — Spiggle & Theis Medizintechnik GmbH · Class I
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- EZU-PA5O-14 — FUJIFILM Corporation · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
- MP-2794-G16 — FUJIFILM Corporation · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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 |
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Manufacturer
- Manufacturer
- Bk Medical ApS
Sources (1)
- FDA UDI 3b647329-e2b7-4602-a890-6154f0c49c29 35 fields · synced Jun 1, 2026