Acucise® Endopyelotomy System
GUDID 10607915111677
General Purpose Ureteral Catheter
APPLIED MEDICAL RESOURCES CORPORATION
Ureteral catheter| Primary Device ID | 10607915111677 |
| NIH Device Record Key | 577596af-3c5f-4648-aa80-ed9a2bd61f85 |
| Commercial Distribution Discontinuation | 2019-03-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Acucise® Endopyelotomy System |
| Version Model Number | B1201 |
| 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 |
Customer Support Contacts
| 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 Dimensions
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Catheter Gauge | 7 French |
| Length | 78 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 7 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915111670 [Primary] |
| GS1 | 10607915111677 [Package] Contains: 00607915111670 Package: [1 Units] Discontinued: 2019-03-25 Not in Commercial Distribution |
FDA Product Code
| EYB | Catheter, Ureteral, Gastro-Urology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-15 |
| Device Publish Date | 2016-08-22 |
On-Brand Devices [Acucise® Endopyelotomy System]
| 10607915111677 | General Purpose Ureteral Catheter |
| 10607915111660 | Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT |
Trademark Results [Acucise]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUCISE 74266054 1810631 Live/Registered |
Applied Medical Resources Corporation 1992-04-13 |
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