Hydromark CA000515006
GUDID 10841911103643
HydroMark Breast Biopsy Site Marker- Non CE
DEVICOR MEDICAL PRODUCTS, INC.
Radiological image marker, implantable| Primary Device ID | 10841911103643 |
| NIH Device Record Key | 7d374e5b-f866-4faf-abb8-985372e53779 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydromark |
| Version Model Number | 4010-05-08-T4 |
| Catalog Number | CA000515006 |
| Company DUNS | 961832156 |
| Company Name | DEVICOR MEDICAL PRODUCTS, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841911103646 [Primary] |
| GS1 | 10841911103643 [Package] Contains: 00841911103646 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203097
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-06 |
| Device Publish Date | 2024-08-29 |
On-Brand Devices [Hydromark]
| 10841911101694 | HydroMARK Breast Biopsy Site Marker |
| 10841911101571 | HydroMARK Breast Biopsy Site Marker |
| 10841911101564 | HydroMARK Breast Biopsy Site Marker |
| 10841911101557 | HydroMARK Breast Biopsy Site Marker |
| 10841911101540 | HydroMARK Breast Biopsy Site Marker |
| 10841911101533 | HydroMARK Breast Biopsy Site Marker |
| 10841911101526 | HydroMARK Breast Biopsy Site Marker |
| 10841911101519 | HydroMARK Breast Biopsy Site Marker |
| 10841911101502 | HydroMARK Breast Biopsy Site Marker |
| 10841911101496 | HydroMARK Breast Biopsy Site Marker |
| 10841911101489 | HydroMARK Breast Biopsy Site Marker |
| 10841911101472 | HydroMARK Breast Biopsy Site Marker |
| 10841911101465 | HydroMARK Breast Biopsy Site Marker |
| 10841911101458 | HydroMARK Breast Biopsy Site Marker |
| 10841911101441 | HydroMARK Breast Biopsy Site Marker |
| 10841911101434 | HydroMARK Breast Biopsy Site Marker |
| 10841911101427 | HydroMARK Breast Biopsy Site Marker |
| 10841911101410 | HydroMARK Breast Biopsy Site Marker |
| 10841911101403 | HydroMARK Breast Biopsy Site Marker |
| 10841911101397 | HydroMARK Breast Biopsy Site Marker |
| 10841911101380 | HydroMARK Breast Biopsy Site Marker |
| 00841911100201 | HydroMARK Breast Biopsy Site Marker |
| 10841911100192 | HydroMARK Breast Biopsy Site Marker |
| 10841911100185 | HydroMARK Breast Biopsy Site Marker |
| 10841911100178 | HydroMARK Breast Biopsy Site Marker |
| 10841911100161 | HydroMARK Breast Biopsy Site Marker |
| 10841911100154 | HydroMARK Breast Biopsy Site Marker |
| 10841911100147 | HydroMARK Breast Biopsy Site Marker |
| 10841911100130 | HydroMARK Breast Biopsy Site Marker |
| 10841911100123 | HydroMARK Breast Biopsy Site Marker |
| 10841911100116 | HydroMARK Breast Biopsy Site Marker |
| 10841911100109 | HydroMARK Breast Biopsy Site Marker |
| 10841911100093 | HydroMARK Breast Biopsy Site Marker |
| 10841911100086 | HydroMARK Breast Biopsy Site Marker |
| 10841911100079 | HydroMARK Breast Biopsy Site Marker |
| 10841911100062 | HydroMARK Breast Biopsy Site Marker |
| 10841911100055 | HydroMARK Breast Biopsy Site Marker |
| 10841911100048 | HydroMARK Breast Biopsy Site Marker |
| 10841911100031 | HydroMARK Breast Biopsy Site Marker |
| 10841911100024 | HydroMARK Breast Biopsy Site Marker |
| 10841911100017 | HydroMARK Breast Biopsy Site Marker |
| 10841911100000 | HydroMARK Breast Biopsy Site Marker |
| 10841911103674 | HydroMark Breast Biopsy Site Marker -Non CE |
| 10841911103667 | HydroMark Breast Biopsy Site Marker- Non CE |
| 10841911103643 | HydroMark Breast Biopsy Site Marker- Non CE |
| 00841911103639 | HydroMark Breast Biopsy Site Marker- Non CE |
| 00841911103530 | HydroMARK Breast Biopsy Site Marker- CE |
Trademark Results [Hydromark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROMARK 78729955 3600269 Live/Registered |
DEVICOR MEDICAL PRODUCTS, INC. 2005-10-10 |
 HYDROMARK 78221005 2934695 Live/Registered |
KESTER LLC 2003-03-03 |
 HYDROMARK 75604286 not registered Dead/Abandoned |
DevCar. Inc. 1998-12-14 |
 HYDROMARK 74268023 not registered Dead/Abandoned |
LANDMARK GRAPHICS, INC. 1992-04-22 |
 HYDROMARK 72253259 0828438 Dead/Expired |
CLAYTON MARK & COMPANY 1966-08-29 |
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