Identity
- Trade Name
- PAK Needle FDA UDI
- Generic Name
- Stereotactic surgery system probe, single-use FDA UDI
- Model / Reference
- MP6001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212022920 FDA UDI
- 510(k) Number
- K142344 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Stereotactic surgery system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Stereotactic surgery system probe, single-use
PAK Needle by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142344 also covers:
- DISP DYNAMIC REFERENCE FRAME — IZI MEDICAL PRODUCTS LLC
- DISP DYNAMIC REFERENCE FRAME — IZI MEDICAL PRODUCTS LLC
- DPA: BLUNT PROBE AND DRF, PACK — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- Disposable Passive Array - Blunt Probe — IZI MEDICAL PRODUCTS LLC
- ONPOINT NAVIGATION 10 BOX — IZI MEDICAL PRODUCTS LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI da102b98-c3ea-409c-8372-2cf1e801b54a 33 fields · synced May 30, 2026