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Prostate Needle Guide
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989603209113Model Prostate Needle Guide, 16G/18G
Identity
- Trade Name
- Prostate Needle Guide EUDAMEDInvivo FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Prostate Needle Guide EUDAMEDFDA UDI
- Model / Reference
- Prostate Needle Guide, 16G/18G EUDAMED989603209113 EUDAMED98960320911 FDA UDI
- Description
- Prostate Needle Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838073272 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073272 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- Z11050185 MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Prostate Needle Guide by Invivo Corporation — Class I — 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-00884838073272 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 bf253523-c63f-433e-a092-0df5295fa10d 61 fields · synced Jul 21, 2026
- FDA UDI 4d2d4a21-c45f-4962-ad73-287ff2829704 36 fields · synced May 30, 2026