ZeroWet KL-10NS
GUDID 00855364004153
ZeroWet Klenzalac Kit
MAR-MED INC.
Irrigation syringe| Primary Device ID | 00855364004153 |
| NIH Device Record Key | 580ec3ab-2cdf-401f-a243-50cd22b457e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZeroWet |
| Version Model Number | Klenzalac |
| Catalog Number | KL-10NS |
| Company DUNS | 176664068 |
| Company Name | MAR-MED INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com | |
| Phone | 6164543000 |
| info@marmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855364004153 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K900208
FDA Product Code
| KYZ | Syringe, Irrigating (Non Dental) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-23 |
| Device Publish Date | 2025-05-15 |
On-Brand Devices [ZeroWet]
| 00855364004153 | ZeroWet Klenzalac Kit |
| 00855364004146 | Zerowet SuperShield (Individual Unit) |
Trademark Results [ZeroWet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZEROWET 86834454 5002569 Live/Registered |
Zerowet, Inc. 2015-11-30 |
 ZEROWET 74068304 1639652 Dead/Cancelled |
Zerowet, Inc. 1990-06-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.