| Primary Device ID | 00842071106942 |
| NIH Device Record Key | 20087cf4-988f-45ae-86a0-db1d12626962 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMT Guidewire |
| Version Model Number | E4-GW-4 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842071106942 [Primary] |
| KNT | Tubes, Gastrointestinal (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-09-23 |
| 00842071111823 | Guidewire (.038"Dia x180cm, pouched) |
| 00842071106942 | Guidewire (.038"Dia x 90cm, pouched) |
| 00842071106928 | Guidewire (.018"Dia x 70cm, pouched) |
| 00842071130633 | Guidewire (.018"Dia x 45cm, pouched) |
| 00842071136512 | 0.038"Dia x 180cm Guidewire (Pouched), MDR |
| 00842071136505 | 0.038"Dia x 90cm Guidewire (Pouched), MDR |
| 00842071136499 | 0.038" Dia x 45cm Guidewire (Pouched), MDR |
| 00842071136482 | 0.018" Dia x 70cm Guidewire (Pouched), MDR |
| 00842071136475 | 0.018" Dia x 45cm Guidewire (Pouched), MDR |