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Ester One Shot
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GUN1415EC-OSRef GUN1415ECRef ESTER
Identity
- Trade Name
- ESTER ONE SHOT EUDAMEDESTER EUDAMEDGUN1415EC EUDAMEDBiopsybell FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- ESTER ONE SHOT EUDAMEDESTER EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDAutomatic guillotine needle for soft tissue biopsy FDA UDIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
- Model / Reference
- GUN1415EC-OS EUDAMEDGUN1415EC EUDAMEDESTER EUDAMEDFDA UDIEster one shot FDA UDI
- Description
- Automatic guillotine needle for soft tissue biopsy FDA UDIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
Identifiers
- Catalog Number
- GUN1415EC-OS FDA UDIGUN1415EC FDA UDI
- Primary DI / UDI-DI
- 08033860016296 EUDAMEDFDA UDI08033860010294 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860016296 EUDAMEDB-08033860010294 EUDAMED8033860BIOEFT01U5 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 — 150 Millimeter FDA UDINeedle Gauge — 14 Gauge FDA UDI
Ester One Shot by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860016296 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860016296 | 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 (7)
- EUDAMED 30976e88-c2e8-40ad-890b-a405322a62b2 61 fields · synced Jul 12, 2026
- EUDAMED 393ac9cb-6cfd-4980-ba6b-ac6b1bf8bbbf 61 fields · synced May 16, 2026
- EUDAMED 29fd445b-ccd0-4dee-83b3-2816c021e7f2 61 fields · synced May 17, 2026
- EUDAMED cf2b432c-9fb5-4956-8ad7-613721336fd8 61 fields · synced May 19, 2026
- FDA UDI 0d43d19b-216b-4de6-b93b-d40d5712384b 37 fields · synced May 30, 2026
- FDA UDI 50cbf842-ff96-4478-91fd-941ca96b2eb3 37 fields · synced May 30, 2026
- EUDAMED 78199fcc-dbf6-4262-85b8-5be504e6f5d6 61 fields · synced Jul 12, 2026