| Primary Device ID | 10607915113336 |
| NIH Device Record Key | 6013d83d-b21e-4c0d-a29d-c1dd178e266e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Forté® AxP Access Sheath |
| Version Model Number | B7176 |
| 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 | false |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 28 Centimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915113339 [Primary] |
| GS1 | 10607915113336 [Package] Contains: 00607915113339 Package: [6 Units] In Commercial Distribution |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-22 |
| 10607915113558 | Ureteral Dilating Catheter |
| 10607915113534 | Ureteral Dilating Catheter |
| 10607915113510 | Ureteral Dilating Catheter |
| 10607915113497 | Ureteral Dilating Catheter |
| 10607915113350 | Ureteral Dilating Catheter |
| 10607915113336 | Ureteral Stent Placement Set |
| 10607915113299 | Ureteral Stent Placement Set |
| 10607915113275 | Ureteral Stent Placement Set |
| 10607915113220 | Ureteral Stent Placement Set |
| 10607915113206 | Ureteral Stent Placement Set |
| 10607915113183 | Ureteral Stent Placement Set |
| 10607915113169 | Ureteral Stent Placement Set |
| 10607915113145 | Ureteral Stent Placement Set |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
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Corsa Holdings, LLC 2023-01-30 |
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DAE DO INC 2022-11-11 |
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ELANCO TIERGESUNDHEIT AG 2022-10-04 |
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Forte Labs, Inc. 2022-09-09 |