FDA UDI
In Commercial Distribution
🇺🇸 United States
ONPOINT SPHERZ PASSIVE MARKER-12 PACK
DI: 00815212026843
·
Model: DS0211201
·
Izi Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ONPOINT SPHERZ PASSIVE MARKER-12 PACK
- Primary DI
- 00815212026843
- Version / Model
- DS0211201
- Company Name
- Izi Medical Products, LLC
- Labeler DUNS
- 933506164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-27
- Public Version
- 1
- Public Version Date
- 2024-03-06
- Public Version Status
- New
- Public Device Record Key
- cbf25dc5-5ece-4532-ad46-a684a7f74047
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66941 | Radiological image marker, noninvasive, single-use | A non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker or clip, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815212026843 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022074 | 000 |