Identity
- Trade Name
- Aldahol 1.8 FDA UDI
- Generic Name
- Glutaraldehyde device sterilant FDA UDI
- Model / Reference
- 4 x 1 gallon case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857635006040 FDA UDI
- 510(k) Number
- K113015 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
No
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
Aldahol 1.8 by Alden Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113015 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 II | Pending data |
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Manufacturer
- Manufacturer
- Alden Medical Llc
Sources (1)
- FDA UDI 90609dac-4efc-4f00-ad45-450e09125a18 33 fields · synced May 30, 2026