SenoMark® Ultra Breast Tissue Marker SMEC10C
GUDID 10801741032025
SENOMARK® ULTRA Breast Tissue Marker, 10 Ga EnCor, BioDur Coil
Bard Peripheral Vascular, Inc.
Imaging lesion localization marker, implantable| Primary Device ID | 10801741032025 |
| NIH Device Record Key | 20bc2d69-5a4f-432b-8b1b-f12fcf1fa054 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SenoMark® Ultra Breast Tissue Marker |
| Version Model Number | SMEC10C |
| Catalog Number | SMEC10C |
| Company DUNS | 135057938 |
| Company Name | Bard Peripheral Vascular, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
| Needle Gauge | 10 Gauge |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741032028 [Primary] |
| GS1 | 10801741032025 [Package] Contains: 00801741032028 Package: CA [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123911
FDA Product Code
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-01 |
On-Brand Devices [SenoMark® Ultra Breast Tissue Marker]
| 10801741032131 | SENOMARK® ULTRA Breast Tissue Marker, 9 Ga Eviva, Titanium Ribbon |
| 10801741032124 | SENOMARK® ULTRA Breast Tissue Marker, 9 Ga Eviva, BioDur Coil |
| 10801741032117 | SENOMARK® ULTRA Breast Tissue Marker, 12 Ga ATEC, Titanium Ribbon |
| 10801741032100 | SENOMARK® ULTRA Breast Tissue Marker, 12 Ga ATEC, BioDur Coil |
| 10801741032094 | SENOMARK® ULTRA Breast Tissue Marker, 9 Ga ATEC, Titanium Ribbon |
| 10801741032087 | SENOMARK® ULTRA Breast Tissue Marker, 9 Ga ATEC, BioDur Coil |
| 10801741032070 | SENOMARK® ULTRA Breast Tissue Marker, 11 Ga Mammotome, Titanium Ribbon |
| 10801741032063 | SENOMARK® ULTRA Breast Tissue Marker, 11 Ga Mammotome, BioDur Coil |
| 10801741032056 | SENOMARK® ULTRA Breast Tissue Marker, 12 Ga EnCor, Titanium Ribbon |
| 10801741032049 | SENOMARK® ULTRA Breast Tissue Marker, 12 Ga EnCor, BioDur Coil |
| 10801741032032 | SENOMARK® ULTRA Breast Tissue Marker, 10 Ga EnCor, Titanium Ribbon |
| 10801741032025 | SENOMARK® ULTRA Breast Tissue Marker, 10 Ga EnCor, BioDur Coil |
| 10801741032018 | SENOMARK® ULTRA Breast Tissue Marker, 7 Ga EnCor, Titanium Ribbon |
| 10801741032001 | SENOMARK® ULTRA Breast Tissue Marker, 7 Ga EnCor, BioDur Coil |
Trademark Results [SenoMark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENOMARK 79013114 3090510 Dead/Cancelled |
B.R.A.H.M.S. Aktiengesellschaft 2005-05-27 |
 SENOMARK 77226091 3394578 Live/Registered |
C. R. BARD, INC. 2007-07-10 |
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