Identity
- Trade Name
- Philips FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Grid dS Breast 16CH I/T; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Block 14G; MRI Needle Block 16G; 2 Needle Block Holder; 2 Fiducial Marker Grid Block Assembly; 4 Lateral Grid, Lower dS Breast 16Ch I/T. FDA UDI
- Model / Reference
- 989603207974 FDA UDI
- Description
- dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Grid dS Breast 16CH I/T; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Block 14G; MRI Needle Block 16G; 2 Needle Block Holder; 2 Fiducial Marker Grid Block Assembly; 4 Lateral Grid, Lower dS Breast 16Ch I/T. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838118768 FDA UDI
- FDA Product Code
- PXP FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Needle guide, single-useNeedle guide, reusable
Philips by Philips Medical Systems Nederland B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 927d6c0a-a0d6-4402-a242-60a23abc3a6a 35 fields · synced Sep 18, 2026