StarchMark® Breast Tissue Marker STMKMT11GSS
GUDID 10801741032186
STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
SENORX, INC.
Imaging lesion localization marker, implantable| Primary Device ID | 10801741032186 |
| NIH Device Record Key | a2758072-cda4-44b1-ad53-5b077b4a6b2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StarchMark® Breast Tissue Marker |
| Version Model Number | STMKMT11GSS |
| Catalog Number | STMKMT11GSS |
| 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 | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 Gauge |
| Needle Gauge | 11 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 | 00801741032189 [Primary] |
| GS1 | 10801741032186 [Package] Contains: 00801741032189 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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