| Primary Device ID | 00842071130602 | 
| NIH Device Record Key | 2c7b2ab6-e371-49b6-9cb1-b5be20ed5a14 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AMT Initial Placement Dilator Set | 
| Version Model Number | IP-DIL-10 | 
| Catalog Number | IP-DIL-10 | 
| 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 | true | 
| 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 | 
| 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 | 00842071130602 [Primary] | 
| 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 | 2020-11-10 | 
| Device Publish Date | 2020-11-02 | 
| 00842071106867 | AMT Initial Placement Dilator Set | 
| 00842071130602 | AMT Initial Placement Dilator Set (10F) | 
| 00842071131876 | AMT Initial Placement Dilator Kit (Smaller Dia GW) | 
| 00842071140182 | AMT Initial Placement Dilator Kit (10F), MDR | 
| 00842071140175 | AMT Initial Placement Dilator Kit, MDR |