Identity
- Trade Name
- Sterile transrectal needle guide with sheath FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer FDA UDI
- Model / Reference
- Single Unit FDA UDI
- Description
- Sterile transrectal needle guide with sheath for use with the Exact Imaging EV29L Transducer FDA UDI
Identifiers
- Catalog Number
- EV-29L-TRK-1 FDA UDI
- Primary DI / UDI-DI
- 00628055481157 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Needle guide, single-use 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
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
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
Sterile transrectal needle guide with sheath by Exact Imaging — 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
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- 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
- Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
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 cfbc9ee1-8e91-4d59-8452-f878ddb77f63 34 fields · synced May 30, 2026