FDA UDI
In Commercial Distribution
🇺🇸 United States
MNAV FIDUCIAL MARKERS
DI: 00815212026676
·
Model: 960-991
·
Izi Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MNAV FIDUCIAL MARKERS
- Primary DI
- 00815212026676
- Version / Model
- 960-991
- Company Name
- Izi Medical Products, LLC
- Labeler DUNS
- 933506164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-16
- Public Version
- 1
- Public Version Date
- 2023-11-24
- Public Version Status
- New
- Public Device Record Key
- 560ec20c-34c5-4aaa-9dcd-392f1c6ac29b
Device Description
FIDUCIAL MARKERS AND SKIN MARKER PEN
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 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 |
|---|---|---|---|---|---|---|
| Package | 10815212026673 | GS1 | Bag | 1 | In Commercial Distribution | |
| Primary | 00815212026676 | GS1 | ||||
| Previous | 00815212020261 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014022 | 000 |