EnCor EnCompass™ ENCPST

GUDID 00801741234194

EnCor EnCompass™ Breast Biopsy and Tissue Removal System Stereotactic Adapter

Bard Peripheral Vascular, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 00801741234194
• NIH Device Record Key: 946b69fd-38eb-4a02-9df1-818faf53a232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnCor EnCompass™
• Version Model Number: ENCPST
• Catalog Number: ENCPST
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Immerse in Any Liquid
• 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 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Wipe with Damp Cloth
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Immerse in Any Liquid
• 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 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Wipe with Damp Cloth

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741234194 [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