| Primary Device ID | 00857252004023 |
| NIH Device Record Key | dd56c03e-37ed-4367-bdfd-d214414fa956 |
| Commercial Distribution Discontinuation | 2020-01-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Accordion Stone Management Device |
| Version Model Number | PA1205-06-10 |
| Catalog Number | PA1205-06-10 |
| Company DUNS | 101084796 |
| Company Name | T H S INTERNATIONAL, 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 | 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 | 317-759-2869 |
| sales@accordionmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857252004023 [Primary] |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2016-06-06 |
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| 00857252004016 - Accordion Stone Control Device; Accordion Stone Management Device | 2020-01-27 Accordion Stone Control Device; Accordion Stone Management Device |
| 00857252004023 - Accordion Stone Management Device | 2020-01-27Accordion Stone Management Device |
| 00857252004023 - Accordion Stone Management Device | 2020-01-27 Accordion Stone Management Device |
| 00857252004030 - Accordion Piccolo Stone Management Device | 2020-01-27 Accordion Piccolo Stone Management Device |