| Primary Device ID | 00842071148966 |
| NIH Device Record Key | 4b68066e-65b2-4221-bd23-615482cae7a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMT Stiffener for Initial Placement |
| Version Model Number | E4-6200 |
| Catalog Number | E4-6200, 4-6200 |
| 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 | 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 | (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 | 00842071148959 [Primary] |
| GS1 | 00842071148966 [Package] Contains: 00842071148959 Package: Box (4-6200) [10 Units] In Commercial Distribution |
| KNT | Tubes, Gastrointestinal (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 00842071111809 | Guidewire Compatible Stiffener for Initial Placement (Pouched) |
| 00842071130626 | Guidewire Compatible Stiffener for Initial Placement, 10F Compatible (Pouched) |
| 00842071131173 | Introducer / Stiffener for Initial Placement (Long Length, Pouched) |
| 00842071148966 | Guidewire Compatible Stiffener for Initial Placement (Longer Length, Pouched), MDR |
| 00842071136376 | Guidewire Compatible Stiffener for Initial Placement (Pouched), MDR |