| Primary Device ID | 10855683006576 |
| NIH Device Record Key | 2e93365b-42a2-46dd-9d8a-a30fcb93f753 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Delphinus Sequr™ |
| Version Model Number | Breast Interface |
| Catalog Number | 99-176-780962 |
| Company DUNS | 002449593 |
| Company Name | PARKER LABORATORIES INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com | |
| Phone | 973-276-9500 |
| customerservice@parkerlabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855683006579 [Primary] |
| GS1 | 10855683006576 [Package] Contains: 00855683006579 Package: Inner Box [6 Units] In Commercial Distribution |
| GS1 | 20855683006573 [Package] Package: Master Case [6 Units] In Commercial Distribution |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-03-17 |
| Device Publish Date | 2023-01-24 |
| 10855683006576 - Delphinus Sequr™ | 2026-03-17Delphinus Sequr™ Breast Interface - GEL PAD |
| 10855683006576 - Delphinus Sequr™ | 2026-03-17 Delphinus Sequr™ Breast Interface - GEL PAD |
| 10303410000019 - Aquaflex | 2025-06-09 Profound 2cm wide gel pad |
| 20855683006962 - ULTRADRAPE 2 | 2025-05-28 Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in |
| 10303410000033 - Aquaflex | 2024-11-28 Profound 3cm narrow gel pad |
| 10303410000026 - Aquaflex | 2024-09-05 Profound 3cm wide gel pad |
| 10855683006347 - ECLIPSE | 2024-06-05 Eclipse Probe Cover-latex free, 64 mm / 44 x 241 mm |
| 10855683006354 - ECLIPSE | 2024-06-05 Eclipse Probe Cover, 83mm/43x241mm |
| 10855683006361 - AQUAGEL | 2024-06-05 Aquagel Lubricating Gel, 5 oz. tube |