FDA UDI
In Commercial Distribution
🇺🇸 United States
TomoSPOT
DI: 00815137020506
·
Model: 783
·
Beekley Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
273
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Basic Information
- Brand Name
- TomoSPOT
- Primary DI
- 00815137020506
- Version / Model
- 783
- Company Name
- Beekley Corporation
- Labeler DUNS
- 001157841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 273
- Record Status
- Published
- Publish Date
- 2019-07-22
- Public Version
- 2
- Public Version Date
- 2024-09-04
- Public Version Status
- Update
- Public Device Record Key
- 0417cfec-a212-4c5f-b7d8-adbf0e51167f
Device Description
Scar Markers, low density see-through line, pinch-free material
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00815137020506 | GS1 | ||||
| Unit of Use | 10815137020503 | GS1 |