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Ultra-Pro e™ Variable Angle Needle Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 610-1134
Identity
- Trade Name
- Ultra-Pro e™ Variable Angle Needle Guide EUDAMEDFDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- General Purpose Guidance – In-Plane, Open Channel (ultra pro E guide) EUDAMEDUltra-Pro e™ Variable Angle Needle Guide FDA UDISterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover FDA UDI
- Model / Reference
- 610-1134 EUDAMED610-1082 FDA UDI610-1134, 610-1223 FDA UDI
- Description
- Ultra-Pro e™ Variable Angle Needle Guide FDA UDISterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover FDA UDI
Identifiers
- Catalog Number
- 610-1082 FDA UDI610-1134, 610-1223 FDA UDI
- Primary DI / UDI-DI
- 10841436102206 EUDAMEDFDA UDI10841436101940 FDA UDI
- Basic UDI-DI
- 0841436101TD101C2NF EUDAMED
- FDA Product Code
- IYO 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
- 892.1560 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
No
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
- Needle Gauge — 16 Gauge FDA UDILength — 1.3 Inch FDA UDIHeight — 1.3 Inch FDA UDILength — 1.6 Inch FDA UDI
Category: Needle guide, single-use
Ultra-Pro e™ Variable Angle Needle Guide by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Needle guide, single-use.
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- 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
K092619 also covers:
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC.
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Siemens Endocavity Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Tracking Bracket — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (3)
- FDA UDI 2a3e614a-b494-453c-b66a-1b436eeffaf3 38 fields · synced Jul 9, 2026
- FDA UDI 54cb5828-68c3-4456-8efb-1d45ce0eaf77 38 fields · synced May 30, 2026
- EUDAMED e319e405-8342-435a-a433-4f62fb19620c 61 fields · synced Jul 9, 2026