Identity
- Trade Name
- Disposable Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Disposable needle guide for 5C1e (9085) FDA UDI
- Model / Reference
- UA1344 FDA UDI
- Description
- Disposable needle guide for 5C1e (9085) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05704916000967 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Category: Needle guide, single-use
Disposable Needle Guide by Bk Medical ApS — Class II — FDA UDI — listed in FDA GUDID — 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
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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
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Cleared under the same submission
K173569 also covers:
K180737 also covers:
K223830 also covers:
- Dummy Channel Bracket — Bk Medical ApS
- Dummy Channel Bracket — Bk Medical ApS
- Foot Switch — Bk Medical ApS
- Rectosigmoidoscope with Obturator — Bk Medical ApS
- Rectosigmoidoscope with Obturator — Bk Medical ApS
- Water Standoff Collar — Bk Medical ApS
- Wireless Remote Control — Bk Medical ApS
- Wireless Remote Control — Bk Medical ApS
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 9d7e8c84-0d67-4d55-993a-3053c3f074af 35 fields · synced May 30, 2026