Identity
- Trade Name
- ONPOINT SPHERZ PASSIVE MARKER-12 PACK FDA UDI
- Generic Name
- Radiological image marker, noninvasive, single-use FDA UDI
- Model / Reference
- DS0211201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212026843 FDA UDI
- 510(k) Number
- K022074 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Radiological image marker, noninvasive, 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
Yes
FDA UDI
Category: Radiological image marker, noninvasive, single-use
Onpoint Spherz Passive Marker-12 Pack by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological image marker, noninvasive, single-use.
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Cleared under the same submission
K022074 also covers:
- 7D SNAP ON SPHERZ - 4 PACK — IZI MEDICAL PRODUCTS LLC
- 7D SNAP ON SPHERZ - 5 PACK — IZI MEDICAL PRODUCTS LLC
- ACCELUS SNAP ON SPHERZ - 4 PACK — IZI MEDICAL PRODUCTS LLC
- ACCELUS SNAP ON SPHERZ - 80 PACK — IZI MEDICAL PRODUCTS LLC
- ORTHO-KEY — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — IZI MEDICAL PRODUCTS LLC
- Quick Spherz — 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 cbf25dc5-5ece-4532-ad46-a684a7f74047 33 fields · synced May 30, 2026