EnCor EnCompass™

Basic Information

• Brand Name: EnCor EnCompass™
• Primary DI: 10801741234184
• Version / Model: ENCPBag
• Catalog Number: ENCPBag
• Company Name: Bard Peripheral Vascular, Inc.
• Labeler DUNS: 135057938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2026-02-09
• Public Version: 1
• Public Version Date: 2026-02-17
• Public Version Status: New
• Public Device Record Key: ea2b656d-a3b3-4cc4-b8d4-ef0a58b6b3f3

Device Description

EnCor EnCompass™ Breast Biopsy and Tissue Removal System Canister Liner Bag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNW	Instrument, biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00801741234187	GS1
Primary	10801741234184	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252681	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry