| Primary Device ID | 10827002476469 |
| NIH Device Record Key | 1d55e78f-248e-403e-8eae-b2a954c5c580 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultraxx |
| Version Model Number | G47646 |
| Catalog Number | UNBS-6-15-CS-01 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Avoid Exposure to light. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002476469 [Primary] |
| LJE | CATHETER, NEPHROSTOMY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-11 |
| Device Publish Date | 2020-08-03 |
| 00827002576209 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe |
| 00827002576193 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe |
| 00827002576186 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe |
| 00827002576179 | Ultraxx Nephrostomy Balloon with TFE Sheath |
| 00827002576162 | Ultraxx Nephrostomy Balloon with TFE Sheath |
| 00827002576155 | Ultraxx Nephrostomy Balloon with TFE Sheath |
| 10827002476582 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 10827002476490 | Ultraxx Nephrostomy Balloon Set |
| 10827002476483 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 10827002476476 | Ultraxx Nephrostomy Balloon Set |
| 10827002476469 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 10827002476452 | Ultraxx Nephrostomy Balloon Set |
| 00827002476585 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002476493 | Ultraxx Nephrostomy Balloon Set |
| 00827002476486 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002476479 | Ultraxx Nephrostomy Balloon Set |
| 00827002476462 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002476455 | Ultraxx Nephrostomy Balloon Set |
| 00827002460386 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002460379 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002460362 | Ultraxx Nephrostomy Balloon Set |
| 00827002460355 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002460348 | Ultraxx Nephrostomy Balloon |
| 00827002460331 | Ultraxx Nephrostomy Balloon |
| 00827002460249 | Ultraxx Nephrostomy Balloon Set |
| 00827002460232 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002303652 | Ultraxx Nephrostomy Balloon Set |
| 00827002303645 | Ultraxx Nephrostomy Balloon With TFE Sheath |
| 00827002303584 | Ultraxx Nephrostomy Balloon Clear Amplatz Sheath With Radiopaque Stripe |
| 00827002303577 | Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe |