FDA UDI
In Commercial Distribution
🇺🇸 United States
Wavicide-01
DI: M44501041GLIRI0
·
Model: 0104-1gl IRI
·
MEDICAL CHEMICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Wavicide-01
- Primary DI
- M44501041GLIRI0
- Version / Model
- 0104-1gl IRI
- Catalog Number
- 0104-1gl IRI
- Company Name
- MEDICAL CHEMICAL CORPORATION
- Labeler DUNS
- 008496861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 65a97b29-f1cc-4af5-8f8e-0766bfa5225e
Device Description
Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MED | Sterilant, Medical Devices | General Hospital | 880.6885 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40579 | Glutaraldehyde device sterilant | A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M44501041GLIRI1 | HIBCC | Box | 12 | In Commercial Distribution | |
| Primary | M44501041GLIRI0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914749 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze