| Primary Device ID | 10607915137912 |
| NIH Device Record Key | 525bea45-631a-46e7-8275-e8fc66153a98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GelPOINT Path Transanal Access Platform |
| Version Model Number | CNB10 |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| 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 | 1-949-713-8300 |
| contact@appliedmedical.com | |
| Phone | 1-949-713-8300 |
| contact@appliedmedical.com | |
| Phone | 1-949-713-8300 |
| contact@appliedmedical.com |
| Length | 4 Centimeter |
| Length | 4 Centimeter |
| Length | 4 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915137915 [Primary] |
| GS1 | 10607915137912 [Package] Contains: 00607915137915 Package: [1 Units] In Commercial Distribution |
| FER | Anoscope And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-26 |
| Device Publish Date | 2018-04-03 |
| 10607915137929 | Transanal Access Platform with Insufflation Stabilization Bag |
| 10607915137912 | Transanal Access Platform with Insufflation Stabilization Bag |
| 10607915137301 | Transanal Access Platform with Insufflation Stabilization bag |