| Primary Device ID | 00827002012905 |
| NIH Device Record Key | e729423b-94a6-485f-a8ef-78ad595bf47f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bentson |
| Version Model Number | G01290 |
| Catalog Number | TSFB-35-180 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002012905 [Primary] |
| DQX | WIRE, GUIDE, CATHETER |
| 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 | 2016-09-24 |
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| 00827002145900 | Bentson PTFE Wire Guide With 15cm Flexible Tip |
| 00827002145894 | Bentson PTFE Wire Guide With 15cm Flexible Tip |
| 00827002068056 | Bentson Wire Guide 10cm Distal Flexibility with Softened Tip |
| 00827002043046 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002041943 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002040113 | Fixed Core Bentson Curved |
| 00827002037496 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002024991 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002024304 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002023949 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002020191 | Fixed Core Bentson Curved |
| 00827002020184 | Fixed Core Bentson Curved |
| 00827002017504 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002017016 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002016163 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002014312 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002013698 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002013155 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002012912 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002012905 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002012820 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002010956 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002010635 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002010628 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002009240 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002008656 | Fixed Core Bentson Curved |
| 00827002008564 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002007932 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002006935 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002006928 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002006911 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002006881 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002288737 | Bentson Wire Guide 20cm Distal Flexibility with Softened Tip |
| 00827002288430 | Fixed Core Bentson Curved |
| 00827002270411 | Bentson Wire Guide |
| 00827002156029 | Bentson Hydrophilic Wire Guide With 15cm Flexible Tip |