Identity
- Trade Name
- MRI Needle Sleeve 16G EUDAMEDKITS (Disposables) FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Guidance EUDAMEDNeedle Sleeve FDA UDI
- Model / Reference
- 989603204313 EUDAMEDMRI Needle Sleeve 16G FDA UDI
- Description
- Needle Sleeve FDA UDI
Identifiers
- Catalog Number
- 989603204313 FDA UDI
- Primary DI / UDI-DI
- 00884838072992 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838072992 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- 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
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 — 16 Gauge FDA UDI
MRI Needle Sleeve 16G 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-00884838072992 | Class I | No Longer Active |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 b85d90d2-0f6b-4539-be6d-cb7242abc6a7 61 fields · synced Jun 18, 2026
- FDA UDI bf744fed-0148-4f2f-89b9-966c11042808 37 fields · synced May 24, 2026