Identity
- Trade Name
- Biopsy Starter Kit FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Starter Kit for Ultrasonix L14-5/38 & L9-4/38 Ultrasound Transducers FDA UDI
- Model / Reference
- 7257 FDA UDI
- Description
- Biopsy Starter Kit for Ultrasonix L14-5/38 & L9-4/38 Ultrasound Transducers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841912103348 FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- 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
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
High-level Disinfectant FDA UDI
Category: Needle guide, single-useUltrasound imaging system tracking positioner, reusable
Biopsy Starter Kit by Protek Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound imaging system tracking positioner, reusable.
- BIOPSY ADAPTOR — Canon Medical Systems Corporation · Class II
- Needle Guide Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- NGB-025 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Verza Guidance System — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- NGB-003 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Verza Guidance System — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI 11815e7b-7e45-498d-b0b4-98135fa84952 33 fields · synced May 31, 2026