Amplatz ARI-180016-01
GUDID 00827002574632
Amplatz Renal Introducer
COOK INCORPORATED
Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use| Primary Device ID | 00827002574632 |
| NIH Device Record Key | 039b1abc-52a0-430b-969e-479b3e039311 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplatz |
| Version Model Number | G57463 |
| Catalog Number | ARI-180016-01 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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. |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002574632 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172527
FDA Product Code
| LJE | CATHETER, NEPHROSTOMY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-04 |
| Device Publish Date | 2020-08-27 |
On-Brand Devices [Amplatz]
| 00827002149755 | PTFE Amplatz Extra Stiff Wire Guide |
| 00827002146938 | PTFE Amplatz Extra Stiff Wire Guide |
| 00827002146310 | PTFE Amplatz Stiff Wire Guide |
| 00827002145047 | Amplatz Renal Dilator Set |
| 00827002144859 | Amplatz Renal Dilator Set |
| 00827002143050 | Catheter For Use With Amplatz Renal Dilator Set |
| 00827002142923 | Amplatz Renal Dilator Set |
| 00827002128071 | Amplatz Renal Dilator Set |
| 00827002124936 | Amplatz Extra Stiff Whisker Wire Guide |
| 00827002122321 | Amplatz Extra Stiff Whisker Wire Guide |
| 00827002121072 | Amplatz Extra Stiff Wire Guide |
| 00827002120495 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002119741 | Amplatz Universal Drainage Catheter Ultrathane |
| 00827002118379 | Amplatz Extra Stiff Wire Guide |
| 00827002116856 | Amplatz Extra Stiff Wire Guide |
| 00827002116849 | Amplatz Extra Stiff Wire Guide |
| 00827002116757 | Amplatz Extra Stiff Wire Guide |
| 00827002116740 | Amplatz Extra Stiff Wire Guide |
| 00827002116436 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002113671 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002112551 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002112544 | TFE Coated Curved Amplatz Extra Stiff Wire Guide |
| 00827002106529 | Amplatz Ultra Stiff Wire Guide |
| 00827002106482 | Amplatz Extra Stiff Whisker Wire Guide |
| 00827002105485 | Amplatz Ultra Stiff Wire Guide |
| 00827002105232 | Amplatz Ultra Stiff Wire Guide |
| 00827002101814 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002101692 | Amplatz Ultra Stiff Wire Guide |
| 00827002101685 | Amplatz Ultra Stiff Wire Guide |
| 00827002100565 | Amplatz Ultra Stiff Wire Guide |
| 00827002100541 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002100527 | Amplatz Ultra Stiff Wire Guide |
| 00827002100510 | Amplatz Ultra Stiff Wire Guide |
| 00827002099890 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002099777 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002099609 | Amplatz Ultra Stiff Wire Guide |
| 00827002099579 | Amplatz Ultra Stiff Wire Guide |
| 00827002099562 | Amplatz Ultra Stiff Wire Guide |
| 00827002099555 | Amplatz Ultra Stiff Wire Guide |
| 00827002099548 | Amplatz Ultra Stiff Wire Guide |
| 00827002098657 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002098473 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097155 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097148 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097131 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097124 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097117 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097100 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097094 | Amplatz Ureteral Stent Set Ultrathane |
| 00827002097087 | Amplatz Ureteral Stent Set Ultrathane |
Trademark Results [Amplatz]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLATZ 72134662 0759758 Dead/Expired |
NEDMAC, INC. 1961-12-26 |
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