Identity
- Trade Name
- Sterile transperineal needle guide with sheath FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile transperineal needle guide with sheath for use with the EV29L transducer. FDA UDI
- Model / Reference
- Single Unit FDA UDI
- Description
- Sterile transperineal needle guide with sheath for use with the EV29L transducer. FDA UDI
Identifiers
- Catalog Number
- EV-29L-TPK-1 FDA UDI
- Primary DI / UDI-DI
- 00628055481102 FDA UDI
- 510(k) Number
- K192303 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 transperineal 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
Cleared under the same submission
K192303 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 36389be4-ef19-447a-8390-fd01a393279e 35 fields · synced May 30, 2026