EnCor EnCompass™ ENCP12G
GUDID 10801741234115
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Probe – 12G, TriConcave™
Bard Peripheral Vascular, Inc.
Soft-tissue biopsy procedure kit, non-medicated| Primary Device ID | 10801741234115 |
| NIH Device Record Key | a0d29872-4a58-4c8e-bf93-c70921387b36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnCor EnCompass™ |
| Version Model Number | ENCP12G |
| Catalog Number | ENCP12G |
| 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 |
| 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 | |
| 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 |
Device Dimensions
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
| Needle Gauge | 12 Gauge |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| 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 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741234118 [Primary] |
| GS1 | 10801741234115 [Package] Contains: 00801741234118 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K252681
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 | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
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™ |
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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