Identity
- Trade Name
- Invivo FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- Baseplate Assembly, GEMS FDA UDI
- Model / Reference
- 4535-303-24921 FDA UDI
- Description
- Baseplate Assembly, GEMS FDA UDI
Identifiers
- Catalog Number
- 989603112281 FDA UDI
- Primary DI / UDI-DI
- 00884838081796 FDA UDI
- FDA Product Code
- GDF FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Invivo by Philips DS North America LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips DS North America LLC
Sources (1)
- FDA UDI fde91575-b755-4f39-94e0-a5584c448218 37 fields · synced Jun 8, 2026