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Fully Automatic Biopsy Gun
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 989603202953Model Fully Automatic Biopsy Gun, 14G, 150mm
Identity
- Trade Name
- Fully Automatic Biopsy Gun EUDAMEDInvivo FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Fully Automatic Biopsy Gun EUDAMEDFDA UDI
- Model / Reference
- Fully Automatic Biopsy Gun, 14G, 150mm EUDAMED989603202953 EUDAMED98960320295 FDA UDI
- Description
- Fully Automatic Biopsy Gun FDA UDI
Identifiers
- Catalog Number
- 989603202953 FDA UDI
- Primary DI / UDI-DI
- 00884838072534 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838072534 EUDAMED
- 510(k) Number
- K010037 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Radiation Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDILength — 150 Millimeter FDA UDI
Fully Automatic Biopsy Gun by Invivo Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838072534 | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED f8f9cd80-ddb7-4aeb-9108-b798db006f0f 61 fields · synced Oct 6, 2026
- FDA UDI cc8bdd21-3a6d-4fb5-a81e-0ea464a4dfc8 39 fields · synced May 25, 2026