| Primary Device ID | 04048551409954 |
| NIH Device Record Key | a6a575bf-4d21-4809-b502-bcb5192a257a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 40712035 |
| Catalog Number | 40712035 |
| 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 | false |
| Serial Number | true |
| 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 |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com | |
| Phone | +14242188201 |
| regulatory@karlstorz.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048551409954 [Primary] |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
[04048551409954]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-04 |
| Device Publish Date | 2025-03-27 |
| 04048551232378 - n.a. | 2025-08-19 Urethrotome Sheath, 8 Fr. |
| 04048551232781 - n.a. | 2025-08-19 Urethrotome Sheath, 10 Fr. |
| 04048551418123 - n.a. | 2025-08-19 IMAGE1 S 4U-LINK |
| 04048551210567 - n.a. | 2025-08-12 Injection Cannula, diam. 2 mm |
| 04048551210574 - n.a. | 2025-08-12 Injection Cannula, diam. 3 mm |
| 04048551211281 - n.a. | 2025-08-12 Injection Cannula, 8.5 cm |
| 04048551211427 - n.a. | 2025-08-12 Injection Cannula |
| 04048551211694 - n.a. | 2025-08-12 Injection Cannula, 8.5 cm |