| Primary Device ID | 00861361000241 |
| NIH Device Record Key | 2aef0a1e-ead2-4552-8585-d9a402873841 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation Syringe Attachment |
| Version Model Number | 1.0 |
| Catalog Number | ISA-001 |
| Company DUNS | 073724333 |
| Company Name | Biorep Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com | |
| Phone | 3053304449 |
| customerservice@biorep.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861361000234 [Primary] |
| GS1 | 00861361000241 [Package] Contains: 00861361000234 Package: Shelfbox [5 Units] In Commercial Distribution |
| KYZ | Syringe, Irrigating (Non Dental) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-24 |
| Device Publish Date | 2025-02-14 |
| 00861361000241 - Irrigation Syringe Attachment | 2025-02-24The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device is comprised of a Luer slip elbow connector irrigation port with removable Luer cap, a rotatable manifold, and multiple irrigation tubes each with a slidable (repositionable) tapered tip with wings |
| 00861361000241 - Irrigation Syringe Attachment | 2025-02-24 The Irrigating Syringe Attachment is a device that enables a patient to perform self-irrigation of tunneling wounds. The device |
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