FDA UDI
In Commercial Distribution
🇺🇸 United States
Xact
DI: 00854623006136
·
Model: M15R
·
Solstice Corporation
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
60
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Basic Information
- Brand Name
- Xact
- Primary DI
- 00854623006136
- Version / Model
- M15R
- Catalog Number
- M15R
- Company Name
- Solstice Corporation
- Labeler DUNS
- 609823877
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2021-02-26
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- 41c5fc40-9bdf-4931-833b-5969c4c98773
Device Description
X-ray imaging marker for extremities, 15mm circle, 60/box https://xactmarkers.com/product/skeletal-ring-markers-m15r/
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40805 | Radiographic image marker, manual | An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information. | No | Obsolete |
| 47020 | Imaging lesion localization marker, external, single-use | A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10854623006133 | GS1 | ||||
| Primary | 00854623006136 | GS1 |
Customer Contacts
- Phone
- 800-874-7922
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius