Identity
- Trade Name
- ZeroWet FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- ZeroWet Klenzalac Kit FDA UDI
- Model / Reference
- Klenzalac FDA UDI
- Description
- ZeroWet Klenzalac Kit FDA UDI
Identifiers
- Catalog Number
- KL-10NS FDA UDI
- Primary DI / UDI-DI
- 00855364004153 FDA UDI
- 510(k) Number
- K900208 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Irrigation syringe
ZeroWet by Mar-Med Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
- Centurion — Centurion Medical Products · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- IRRIJET® Single-Use — CooperSurgical, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- PROBEVAC — PLASDENT CORP. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Monoject — Cardinalhealth · Class I
Cleared under the same submission
K900208 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mar-Med Co.
Sources (1)
- FDA UDI 580ec3ab-2cdf-401f-a243-50cd22b457e2 36 fields · synced Jun 6, 2026