| Primary Device ID | 00842071149437 |
| NIH Device Record Key | 3cbf3d68-4342-41e3-a9c4-e8dd5d828cf0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RHAPSO |
| Version Model Number | ESD110-C-07 |
| Catalog Number | ESD110-C-07, SD110-C-07-101, SD110-C-07-105 |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| 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 | false |
| 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 | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net | |
| Phone | (440)717-4000 |
| cs@appliedmedical.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071149420 [Primary] |
| GS1 | 00842071149437 [Package] Contains: 00842071149420 Package: Box (SD110-C-07-101) [1 Units] In Commercial Distribution |
| GS1 | 00842071149444 [Package] Contains: 00842071149420 Package: Box (SD110-C-07-105) [5 Units] In Commercial Distribution |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-14 |
| Device Publish Date | 2025-05-06 |
| 00842071149437 | RHAPSO Suture Passer (Curved Needle, Pouched) |
| 00842071149406 | RHAPSO Suture Passer (Straight Needle, Pouched) |