FDA UDI
In Commercial Distribution
🇺🇸 United States
SenoMark® Ultra Breast Tissue Marker
DI: 00801741032035
·
Model: SMEC10R
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SenoMark® Ultra Breast Tissue Marker
- Primary DI
- 00801741032035
- Version / Model
- SMEC10R
- Catalog Number
- SMEC10R
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-01
- Public Version
- 5
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- a640e6bc-4576-41ba-99fd-77070c1e1ac3
Device Description
SENOMARK® ULTRA Breast Tissue Marker, 10 Ga EnCor, Titanium Ribbon
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40808 | Radiological image marker, implantable | A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741032032 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 00801741032035 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123911 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 10 | Gauge |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius