| Primary Device ID | 10365044000032 |
| NIH Device Record Key | 2ab78fb2-22e4-47c8-bb11-6a9c9a5befdc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prick Lancetter™ |
| Version Model Number | 8375ZA |
| Catalog Number | 8375ZA |
| Company DUNS | 119241112 |
| Company Name | Jubilant Hollisterstier LLC |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com | |
| Phone | 800.495.7437 |
| HollisterStier@jubl.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00365044000035 [Primary] |
| GS1 | 10365044000032 [Unit of Use] |
| LDH | System, Delivery, Allergen And Vaccine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2024-11-15 |
| 10365044000001 - Quintest® Multiple Skin Test Device | 2024-11-25 Multiple skin test system with 5 testing legs/tines |
| 10365044000018 - ComforTen® Multiple Skin Test System | 2024-11-25 Multiple skin test system with 10 testing legs/tines |
| 10365044000025 - Quintip® Skin Test Device | 2024-11-25 Disposable self loading test system with 1 testing leg/tine |
| 10365044000032 - Prick Lancetter™ | 2024-11-251 testing leg/tine |
| 10365044000032 - Prick Lancetter™ | 2024-11-25 1 testing leg/tine |
| 10365044000049 - Skin Test Reservoirs | 2024-11-25 Holds testing antigens |
| 00365044000059 - ComforTen® 30-hole covered tray | 2024-11-25 30 hole test tray |
| 00365044000066 - ComforTen® 60-hole covered tray | 2024-11-25 60 hole test tray |
| 00365044000073 - Quintest® Covered Tray | 2024-11-25 60 hole covered test tray |