← Back to catalogue
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Reusable Needle Guide for use with the Exact Imaging EV29L Transducer FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer. FDA UDI
- Model / Reference
- Single Unit FDA UDI
- Description
- The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer. FDA UDI
Identifiers
- Catalog Number
- EV-BIOGR FDA UDI
- Primary DI / UDI-DI
- 00628055481089 FDA UDI
- 510(k) Number
- K180636 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Needle guide, reusable
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer by Exact Imaging — 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
Cleared under the same submission
K180636 also covers:
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
- Exact Imaging
Sources (1)
- FDA UDI 0fb14a12-76bf-4f55-b606-f02a0e3ef486 35 fields · synced May 30, 2026