| Primary Device ID | 10801741109413 |
| NIH Device Record Key | 743d85ec-5a82-48da-a42a-ce5b4714ece5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTRACOR TWIRL |
| Version Model Number | UCTW17 |
| Catalog Number | UCTW17 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Needle Gauge | 17 Gauge |
| Needle Gauge | 17 Gauge |
| Needle Gauge | 17 Gauge |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Size Text, specify | 0 |
| Needle Gauge | 17 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741109416 [Primary] |
| GS1 | 10801741109413 [Package] Contains: 00801741109416 Package: CA [5 Units] In Commercial Distribution |
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-22 |
| 00801741234187 - EnCor EnCompass™ | 2026-02-17 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Canister Liner Bag |
| 10801741234153 - EnCor EnCompass™ | 2026-02-12 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Sample Container |
| 10801741234160 - EnCor EnCompass™ | 2026-02-12 EnCor EnCompass™ Breast Biopsy and Tissue Removal System MRI Extension Tubing |
| 00801741236167 - EnCor EnCompass™ | 2026-02-12 EnCor EnCompass™ Breast Biopsy and Tissue Removal System VisiLoc™ MRI Introducer Set 10G |
| 00801741234194 - EnCor EnCompass™ | 2026-02-11 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Stereotactic Adapter |
| 00801741234248 - EnCor EnCompass™ | 2026-02-11 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Driver |
| 00801741234262 - EnCor EnCompass™ | 2026-02-11 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Foot Switch |
| 00801741235221 - EnCor EnCompass™ | 2026-02-11 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Console |