Identity
- Trade Name
- Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile endocavity needle guide for use with ALPINION E3-10, BK Medical 8819, Hitachi Aloka Medical UST-679, Philips Bp10-5ec, C9-4ec and Samsung Medison NEV4-9ES, NER4-9ES transducers FDA UDI
- Model / Reference
- 610-958 FDA UDI
- Description
- Sterile endocavity needle guide for use with ALPINION E3-10, BK Medical 8819, Hitachi Aloka Medical UST-679, Philips Bp10-5ec, C9-4ec and Samsung Medison NEV4-9ES, NER4-9ES transducers FDA UDI
Identifiers
- Catalog Number
- 610-958 FDA UDI
- Primary DI / UDI-DI
- 10841436104606 FDA UDI
- 510(k) Number
- K970514 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
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
Yes
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Width — 0.853 Inch FDA UDILength — 6.6 Inch FDA UDI
Category: Needle guide, single-use
Needle Guide by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Cleared under the same submission
K970514 also covers:
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
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
- Civco Medical Instruments Co., Inc.
Sources (1)
- FDA UDI fb6a0094-ea9a-41ed-adaf-96aab169be99 38 fields · synced Jun 8, 2026