| Primary Device ID | 00842071109882 |
| NIH Device Record Key | 8981b458-aa1b-427f-88da-669ccaae6c5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Abeon Guyuron E.A.D. |
| Version Model Number | ST8001 |
| Company DUNS | 038101861 |
| Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
| Device Count | 10 |
| 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 | |
| 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 | 00842071109325 [Unit of Use] |
| GS1 | 00842071109882 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 00842071153038 - AMT MiniONE Extension Set | 2026-03-31 12" MiniONE Right Angle Feeding Set with Dual ENFit® Y-Port (Pouched), MDR |
| 00842071149932 - MiniSPC Button | 2026-03-24 14F x 0.8cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set, MDR |
| 00842071149949 - MiniSPC Button | 2026-03-24 14F x 0.8cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set, MDR |
| 00842071149956 - MiniSPC Button | 2026-03-24 14F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set, MDR |
| 00842071149963 - MiniSPC Button | 2026-03-24 14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set, MDR |
| 00842071149970 - MiniSPC Button | 2026-03-24 14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set, MDR |
| 00842071149987 - MiniSPC Button | 2026-03-24 14F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set, MDR |
| 00842071149994 - MiniSPC Button | 2026-03-24 14F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set, MDR |