Peditrol
GUDID 16009900408313
Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of the stones. The irrigation helps to maintain a clear visual field by displacing blood, stone fragments and debris.
WISMED PL SP Z O O
Surgical irrigation tubing set, single-use| Primary Device ID | 16009900408313 |
| NIH Device Record Key | e2681b91-fdc6-40cd-825e-57600756e159 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peditrol |
| Version Model Number | 1 |
| Company DUNS | 850665825 |
| Company Name | WISMED PL SP Z O O |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com | |
| Phone | +1 (513) 604-3430 |
| info@acemedicalco.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06009900408316 [Primary] |
| GS1 | 16009900408313 [Package] Contains: 06009900408316 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 36009900408317 [Package] Contains: 06009900408316 Package: Box [60 Units] In Commercial Distribution |
FDA Product Code
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope |
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 | 2025-03-25 |
| Device Publish Date | 2025-03-17 |
Devices Manufactured by WISMED PL SP Z O O
| 05906168942228 - Dual Action Pump Hand | 2025-04-04 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract |
| 05906168942211 - Dual Action Pump Foot | 2025-03-25 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract |
| 05906168942235 - Sealing Connector Y piece | 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro |
| 05906168942242 - Sealing Connector I Piece | 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro |
| 05906168942259 - Sealing Connector T piece | 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro |
| 16009900408313 - Peditrol | 2025-03-25Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of the stones. The irrigation helps to maintain a clear visual field by displacing blood, stone fragments and debris. |
| 16009900408313 - Peditrol | 2025-03-25 Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of |
| 06009900408330 - Smart Bulb | 2025-03-25 Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and help |
| 06009900408439 - Mini Pillow | 2025-03-25 Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigat |
Trademark Results [Peditrol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEDITROL 85912945 not registered Dead/Abandoned |
Wismed CC 2013-04-24 |
 PEDITROL 79000014 2976284 Dead/Cancelled |
EMS Medical Group Limited 2003-11-06 |
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