| Primary Device ID | 00827002305502 |
| NIH Device Record Key | 611759dc-24ca-43d0-a445-1041ba1bc6b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cystotome |
| Version Model Number | G30550 |
| Catalog Number | CST-10 |
| Company DUNS | 988559035 |
| Company Name | COOK IRELAND LTD |
| 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 | true |
| 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(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry location, away from temperature extremes |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002305502 [Primary] |
| KNS | Unit, electrosurgical, endoscopic (with or without 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 | 2019-02-21 |
| Device Publish Date | 2016-09-24 |
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