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Ester One Shot
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GUN1410ECT-OSRef GUNTR1415ECT-OSRef GUNTRN1410ECT-OSRef GUN1810EC-OSRef GUN1615ECT-OSRef GUNTRN1820ECT-OS
Identity
- Trade Name
- ESTER ONE SHOT EUDAMEDESTER ONE SHOT & INTRODUTTORE EUDAMEDBiopsybell FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDESTER ONE SHOT EUDAMEDAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
- Model / Reference
- GUN1410ECT-OS EUDAMEDGUNTR1415ECT-OS EUDAMEDGUNTRN1410ECT-OS EUDAMEDGUN1810EC-OS EUDAMEDGUN1615ECT-OS EUDAMEDGUNTRN1820ECT-OS EUDAMEDESTER ONE SHOT FDA UDI
- Description
- AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
Identifiers
- Catalog Number
- GUN1810EC-OS FDA UDI
- Primary DI / UDI-DI
- 08033860030926 EUDAMED08033860038472 EUDAMED08033860044404 EUDAMED08033860026417 EUDAMEDFDA UDI08033860038281 EUDAMED08033860044381 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860026417 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS EUDAMED
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Ester One Shot by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (9)
- EUDAMED 188b01fd-9c4e-4578-9e20-98ecac65cc82 61 fields · synced Jul 15, 2026
- EUDAMED 1dc125a3-4e6a-4683-babb-f23c0ebb44e9 61 fields · synced May 16, 2026
- EUDAMED 877975d2-d14e-4f75-b46c-f43e4e6cfe2f 61 fields · synced May 17, 2026
- EUDAMED 905e3b75-0a48-4849-9dd1-4c51b9fd6982 61 fields · synced May 17, 2026
- EUDAMED b181fb98-ee53-4ab4-bb89-ddcb43bc9e2e 61 fields · synced May 17, 2026
- EUDAMED 10694f28-bfff-47a9-a937-6fb539ca3d87 61 fields · synced May 18, 2026
- EUDAMED d58d5071-9277-4e1b-bdfe-8f14c234d411 61 fields · synced May 19, 2026
- FDA UDI c1e8e510-b168-4d5f-986e-f654f9e18ad0 37 fields · synced May 30, 2026
- EUDAMED f46f3217-ff43-4516-a894-61579a74b1c7 61 fields · synced Jul 9, 2026