| Primary Device ID | 00818566019837 |
| NIH Device Record Key | 37e411c8-b374-4956-9707-17f3b4c5f6cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PremierPro TSA High Viscosity Topical Skin Adhesive, 1.0ml |
| Version Model Number | 3470 |
| Catalog Number | 3470 |
| Company DUNS | 831375089 |
| Company Name | SVS LLC |
| Device Count | 1 |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-531-7699 |
| udi@s2sglobal.com | |
| Phone | 1-855-531-7699 |
| udi@s2sglobal.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818566019837 [Primary] |
| GS1 | 10818566019834 [Package] Package: 10/box [10 Units] In Commercial Distribution |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin |
| 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 | 2017-10-19 |
| 00811220035495 - PremierPro | 2024-11-05 Pressure Infusion Bag, Reusable, 500mL, Clear Back |
| 00811220035518 - PremierPro | 2024-11-05 Pressure Infusion Bag, Reusable, 1000mL, Clear Back |
| 10811220035430 - PremierPro | 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove XSmall 200count |
| 10811220035447 - PremierPro | 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove Small 200count |
| 10811220035454 - PremierPro | 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove Medium 200count |
| 10811220035461 - PremierPro | 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove Large 200count |
| 10811220035478 - PremierPro | 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove XLarge 200count |
| 00811220035143 - PremierPro | 2024-02-22 Pre-filled Normal Saline Flush Syringe, 3 mL Fill 0.9% Sodium Chloride Injection, Sterile Fluid Pathway |