| Primary Device ID | 00816342025539 |
| NIH Device Record Key | d42e4cca-763a-46f7-b2f0-b090662b10cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProPass |
| Version Model Number | 20255 |
| Company DUNS | 859961950 |
| Company Name | PARCUS MEDICAL LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816342025539 [Primary] |
| HWQ | Passer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
[00816342025539]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| 00816342025553 | ProPass Suture Passer Needle |
| 00816342025546 | ProPass Suture Passer without trap door |
| 00816342025539 | ProPass Suture Passer with trap door |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROPASS 85236433 4134011 Dead/Cancelled |
World Education Services, Inc. 2011-02-08 |
![]() PROPASS 75351353 2243741 Live/Registered |
HORMEL FOODS, LLC 1997-09-03 |
![]() PROPASS 73400192 1300128 Live/Registered |
Geo. A. Hormel & Company 1982-10-18 |