EnCor EnCompass™ ENCP7GVLOC

GUDID 00801741234200

EnCor EnCompass™ Breast Biopsy and Tissue Removal System VisiLoc™ MRI Introducer Set 7G

Bard Peripheral Vascular, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 00801741234200
• NIH Device Record Key: 4bdf45f8-3140-4c19-b217-da851393f5df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnCor EnCompass™
• Version Model Number: ENCP7GVLOC
• Catalog Number: ENCP7GVLOC
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741234200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161805

FDA Product Code

• KNW: Instrument, biopsy

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: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [EnCor EnCompass™]

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• 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
• 00801741236167: EnCor EnCompass™ Breast Biopsy and Tissue Removal System VisiLoc™ MRI Introducer Set 10G
• 10801741234160: EnCor EnCompass™ Breast Biopsy and Tissue Removal System MRI Extension Tubing
• 10801741234153: EnCor EnCompass™ Breast Biopsy and Tissue Removal System Sample Container
• 00801741234187: EnCor EnCompass™ Breast Biopsy and Tissue Removal System Canister Liner Bag