Calcusplit 27632636
GUDID 04048551086810
CALCUSPLIT® Lithotripsy Wire Probe
Karl Storz GmbH & Co. KG
Pneumatic lithotripsy system probe, urinary| Primary Device ID | 04048551086810 |
| NIH Device Record Key | 2f6f2417-fe6e-4961-8169-c397ab3683ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calcusplit |
| Version Model Number | 27632636 |
| Catalog Number | 27632636 |
| Company DUNS | 315731430 |
| Company Name | Karl Storz GmbH & Co. KG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048551086810 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K981233
FDA Product Code
| FFK | Lithotriptor, electro-hydraulic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
[04048551086810]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-31 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Calcusplit]
| 04048551086896 | CALCUSPLIT® Wire Probe |
| 04048551086872 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086858 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086834 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086810 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086797 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086773 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086698 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086667 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086643 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086599 | CALCUSPLIT-Wire-Probe |
| 04048551086551 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086759 | CALCUSPLIT-Probe |
| 04048551086711 | CALCUSPLIT-Wire-Probe |
| 04048551086629 | CALCUSPLIT-Wire-Probe |
| 04048551086605 | CALCUSPLIT-Wire-Probe |
| 04048551086575 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086537 | CALCUSPLIT® Lithotripsy Wire Probe |
| 04048551086490 | CALCUSPLIT Lithotripsy Probe |
| 04048551086278 | CALCUSPLIT Handpiece |
| 04048551086230 | Adaptor |
| 04048551086087 | CALCUSPLIT-System |
| 04048551018439 | CALCUSPLIT Lithotripsy Probe |
Trademark Results [Calcusplit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALCUSPLIT 75036606 2140009 Live/Registered |
KARL STORZ GMBH & CO. KG 1995-12-26 |
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