EnCor EnCompass™ ENCPDriver
GUDID 00801741234248
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Driver
Bard Peripheral Vascular, Inc.
Mammographic stereotactic biopsy system| Primary Device ID | 00801741234248 |
| NIH Device Record Key | a097083d-98f5-4ba5-b3b0-8795e8cccc31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnCor EnCompass™ |
| Version Model Number | ENCPDriver |
| Catalog Number | ENCPDriver |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com | |
| Phone | +1(800)321-4254 |
| medical.services@BD.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric pressure limitation 500 -1060 hPa |
| Special Storage Condition, Specify | Between 0 and 0 *Wipe with Damp Cloth |
| Special Storage Condition, Specify | Between 0 and 0 *For Indoor Use Only |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Immerse in Any Liquid |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Spray Fluids Directly into the Device |
| Storage Environment Temperature | Between -18 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741234248 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K252681
FDA Product Code
| KNW | Instrument, biopsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-11 |
| Device Publish Date | 2026-02-03 |
On-Brand Devices [EnCor EnCompass™]
| 10801741234177 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 10G, TriConcave™ |
| 10801741234146 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 10G, Blunt Tip |
| 10801741234115 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 12G, TriConcave™ |
| 00801741234200 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System VisiLoc™ MRI Introducer Set 7G |
| 10801741234139 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 7G, Blunt Tip |
| 10801741234092 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 7G, TriConcave™ |
| 00801741235221 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Console |
| 00801741234262 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Foot Switch |
| 00801741234248 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Driver |
| 00801741234194 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System Stereotactic Adapter |
Trademark Results [EnCor EnCompass]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENCOR ENCOMPASS 98169183 not registered Live/Pending |
C. R. Bard, Inc. 2023-09-07 |
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