| Primary Device ID | 10724995183933 |
| NIH Device Record Key | 37047771-f8f9-44a1-b3f7-50f306c1be02 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 00711558 |
| Catalog Number | 00711558 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
| xx@xx.xx |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995183936 [Primary] |
| GS1 | 00816765013571 [Previous] |
| GS1 | 10724995183933 [Package] Contains: 00724995183936 Package: Case [20 Units] In Commercial Distribution |
| NWU | Endoscope introducer kit |
| PRT | Gastric irrigation and aspiration kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2020-04-01 |
| 00724995226732 - Padlock Clip | 2024-11-08 The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and (TouchSoft Coagulator Probe. |
| 10724995197688 - DEFENDO | 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the air/water function of an endosco |
| 10724995217409 - DEFENDO | 2024-07-23 The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit |
| 10724995183278 - VIA | 2024-06-11 The VIA Procedure Kit-custom includes transport pad, gauze, Via Basin, enzymatic sponge, lubricating jelly, suction tubing, gown |
| 00724995227340 - NA | 2023-11-21 gi400 Electrosurgery Unit Evaluation Kit |
| 00724995199296 - truFreeze | 2023-07-19 truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting p |
| 20724995221618 - Ascendo | 2023-07-19 Ascendo Submucosal Lifting Agent |
| 10724995216839 - Torrent | 2023-05-15 The Torrent irrigation scope connector is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile w |