Philips
GUDID 00884838120211
Breast Grid (User-Sterilized)
Philips Medical Systems Nederland B.V.
Needle guide, single-use| Primary Device ID | 00884838120211 |
| NIH Device Record Key | 00f87047-05ff-4e9e-a523-519c53542a43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Philips |
| Version Model Number | 989603214224 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| Device Count | 14 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx | |
| Phone | 1-800-722-9377 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838118799 [Unit of Use] |
| GS1 | 00884838120211 [Primary] |
FDA Product Code
| GDF | Guide, Needle, Surgical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
[00884838120211]
Moist Heat or Steam Sterilization;Liquid Chemical
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-26 |
| Device Publish Date | 2024-07-18 |
On-Brand Devices [Philips]
| 00884838118270 | dS Breast Coil 7ch 1.5T |
| 00884838120242 | Biopsy Grid, Sterilized |
| 00884838120211 | Breast Grid (User-Sterilized) |
| 00884838118782 | BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilizati |
| 00884838118775 | Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Grid Block Assembly; 3 Grid |
| 00884838118768 | dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Gri |
| 00884838118751 | Lateral Grid, Lower dS Breast 16CH I/T |
| 00884838118744 | Lateral Grid, Upper dS Breast 16CH I/T |
| 00884838118737 | Medial Grid dS Breast 16CH I/T |
| 00884838118720 | Lateral Grid dS Breast 16CH I/T |
| 00884838118713 | Grid Plate, Enhanced Access Medial |
| 00884838118706 | Grid Plate Enhanced Access, Lateral |
| 00884838118683 | Pillar Immobilization Plate |
| 00884838118676 | Pillar Immobilization Plate LBS M-L |
| 00884838118669 | Grid Immobilization Plate LBS M-L |
| 00884838118652 | Pillar Immobilization Plate LBS C-C |
| 00884838118645 | Grid Immobilization Plate LBS |
| 00884838118621 | OBC Grid Immobilization Plate |
| 00884838118614 | Mammotome Immobilization Plate |
| 00884838118607 | Pillar Immobilization Plate |
| 00884838118591 | Grid Immobilization Plate |
| 00884838118584 | Needle Hub Assembly |
| 00884838118577 | Fiducial Holder |
| 00884838118560 | Needle Block Holder |
| 00884838118553 | MRI Needle Sleeve18G |
| 00884838118546 | MRI Sleeve Block 16G |
| 00884838118539 | MRI Needle Sleeve 14G |
| 00884838118522 | MRI Needle Sleeve 12G |
| 00884838118515 | MRI Needle Block 18G |
| 00884838118508 | MRI Needle Block 16G |
| 00884838118492 | MRI Needle Block 14G |
| 00884838118485 | MRI Needle Block 12G |
| 00884838118478 | FIDUCIAL MARKER GRID BLOCK ASSEMBLY |
| 00884838118461 | Fiducial Marker Sleeve Assembly |
| 00884838118454 | MRI Needle Block 8G |
Trademark Results [Philips]
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