StarchMark® Breast Tissue Marker STMKEC7GSS
GUDID 10801741032179
STARCHMARK® Breast Tissue Marker, 7 Ga EnCor, SS “V”
SENORX, INC.
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable| Primary Device ID | 10801741032179 |
| NIH Device Record Key | 6f019afd-fabf-4bb6-b64d-0fcdbf34a7bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarchMark® Breast Tissue Marker |
| Version Model Number | STMKEC7GSS |
| Catalog Number | STMKEC7GSS |
| Company DUNS | 043674543 |
| Company Name | SENORX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 Gauge |
| Needle Gauge | 7 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 | 00801741032172 [Primary] |
| GS1 | 10801741032179 [Package] Contains: 00801741032172 Package: CA [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131654
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 | 2015-10-02 |
On-Brand Devices [StarchMark® Breast Tissue Marker]
| 10801741032186 | STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega" |
| 10801741032179 | STARCHMARK® Breast Tissue Marker, 7 Ga EnCor, SS “V” |
| 10801741032162 | STARCHMARK® Breast Tissue Marker, 10 Ga EnCor, SS "Omega" |
Trademark Results [StarchMark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STARCHMARK 77748052 3731151 Live/Registered |
C. R. BARD, INC. 2009-05-29 |
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