Identity
- Trade Name
- Needle Sleeve 18G EUDAMEDInvivo FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Biopsy Guidance EUDAMEDNeedle Sleeve FDA UDI
- Model / Reference
- 989603203513 EUDAMEDNeedle Sleeve 18G FDA UDI
- Description
- Needle Sleeve FDA UDI
Identifiers
- Catalog Number
- 989603203513 FDA UDI
- Primary DI / UDI-DI
- 00884838073005 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838073005 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 — 18 Gauge FDA UDI
Needle Sleeve 18G 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 Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838073005 | Class I | 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 fe5a6173-68f9-4bf8-88ba-3df7d429910b 61 fields · synced Jun 18, 2026
- FDA UDI 8c063968-9cf6-4ca4-aceb-391d8ca15a98 37 fields · synced May 30, 2026