| Primary Device ID | 00607915134440 |
| NIH Device Record Key | 1fb5cfe6-203b-4029-ba92-a82a8778b091 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GelPOINT® Path Transanal Access Platform |
| Version Model Number | CNO11 |
| 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 |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Length | 5.5 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915134440 [Primary] |
| GS1 | 10607915134447 [Package] 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 | 2018-10-30 |
| Device Publish Date | 2016-09-23 |
| 00607915134440 | Transanal Access Platform |
| 10607915127647 | Transanal Access Platform |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GELPOINT 78569466 3175659 Dead/Cancelled |
STAPLES, INC. 2005-02-17 |
![]() GELPOINT 77713830 3753284 Live/Registered |
Applied Medical Resources Corporation 2009-04-14 |
![]() GELPOINT 76127252 2716212 Dead/Cancelled |
Slotta, Mark R. 2000-09-12 |