Identity
- Trade Name
- Wavicide-01 FDA UDI
- Generic Name
- Glutaraldehyde device sterilant FDA UDI
- Device Name
- Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes. FDA UDI
- Model / Reference
- 0104-250gl FDA UDI
- Description
- Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes. FDA UDI
Identifiers
- Catalog Number
- 0104-250gl FDA UDI
- Primary DI / UDI-DI
- M4450104250GL0 FDA UDI
- 510(k) Number
- K914749 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Glutaraldehyde device sterilant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glutaraldehyde device sterilant
Wavicide-01 by Medical Chemical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K914749 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Wavicide-01 — Medical Chemical Corporation
- Wavicide-01 — Medical Chemical Corporation
- Wavicide-01 — Medical Chemical Corporation
- Wavicide-01 — Medical Chemical Corporation
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Biocide G30 — YOUNG DENTAL MANUFACTURING I, LLC
- Biotrol — YOUNG DENTAL MANUFACTURING I, LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medical Chemical Corporation
Sources (1)
- FDA UDI 2358ba29-4616-43d8-818b-f08072fa02da 36 fields · synced Jun 9, 2026