| Primary Device ID | 10817640020551 |
| NIH Device Record Key | 8962b4fb-c340-4284-8bdf-797387fca06e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gravity Drainage Bag |
| Version Model Number | TC600 |
| Catalog Number | TC600 |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
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| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Total Volume | 600 Milliliter |
| Length | 20 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817640020554 [Primary] |
| GS1 | 10817640020551 [Package] Contains: 00817640020554 Package: Dispenser [10 Units] In Commercial Distribution |
| GS1 | 20817640020558 [Package] Package: Shipper [2 Units] In Commercial Distribution |
| GS1 | 30817640020555 [Package] Contains: 00817640020554 Package: Shipper [20 Units] In Commercial Distribution |
| HIBCC | H862TC6000 [Previous] |
| EXF | Bag, Bile Collecting |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-12 |
| Device Publish Date | 2021-11-04 |
| H862TC600L2 | Optimus 600 Gravity Drainage Bag w/36" I.T. |
| H862TC6002 | Optimus 600 Gravity Drainage Bag w/20" I.T. |
| H862PDC362 | Percutaneous Drainage Catheter Connector Tubing |
| 10817640020568 | Optimus 600 Gravity Drainage Bag w/36" I.T. |
| 10817640020551 | Optimus 600 Gravity Drainage Bag w/20" I.T. |