← Back to catalogue
Prostate Needle Guide
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989603208694Model Prostate Needle Guide, 14G
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, 14G EUDAMED989603208694 EUDAMED98960320869 FDA UDI
- Description
- Prostate Needle Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838073289 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073289 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
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-00884838073289 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 49dce7ce-50bc-4abf-bfb5-ed45f76765fe 61 fields · synced Jul 9, 2026
- FDA UDI 3bbe91be-a77d-43cb-833d-b79c68952a6a 37 fields · synced May 30, 2026