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Estacore-Pro Automatic Biopsy Needle
FDA UDIClass II (US FDA UDI)
by Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi
Identity
- Trade Name
- Estacore-Pro Automatic Biopsy Needle FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- This a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula. FDA UDI
- Model / Reference
- GEP1825-S FDA UDI
- Description
- This a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula. FDA UDI
Identifiers
- Catalog Number
- GEP1825-S FDA UDI
- Primary DI / UDI-DI
- 08681672052621 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Side-notch biopsy gun handpiece/needle
Estacore-Pro Automatic Biopsy Needle by Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · 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 |
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Manufacturer
Sources (1)
- FDA UDI 289fb3af-6883-4cda-a018-dfc23d6db471 36 fields · synced May 30, 2026