Identity
- Trade Name
- Needle Guide EUDAMEDFDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Endocavity Guidance (Disposable guide) EUDAMEDSterile endocavity needle guide with (11.9 to 3.8 x 61cm) CIV-Flex™ cover for use with ZONARE E9-4 transducers FDA UDI
- Model / Reference
- 698-014 EUDAMEDFDA UDI
- Description
- Sterile endocavity needle guide with (11.9 to 3.8 x 61cm) CIV-Flex™ cover for use with ZONARE E9-4 transducers FDA UDI
Identifiers
- Catalog Number
- 698-014 FDA UDI
- Primary DI / UDI-DI
- 10841436108048 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD102A1NC EUDAMED
- 510(k) Number
- K970514 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany 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
Yes
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
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
- Length — 6.4 Inch FDA UDIWidth — 1.5 Inch FDA UDI
Category: Needle guide, single-use
Needle Guide by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
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- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Gangi-SoftGuard Coaxial Needle — Apriomed AB · Class II
- TRUGUIDE — Bard Peripheral Vascular · Class II
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 (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
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI 44cb6f5f-5b46-439e-a48b-e44e4bca1547 38 fields · synced Jul 20, 2026
- EUDAMED 8327cc00-3c10-4e58-add9-6f6fe762336d 61 fields · synced Jul 20, 2026