FDA UDI
In Commercial Distribution
🇺🇸 United States
MetriCide
DI: 10615375013516
·
Model: 10-602A
·
METREX RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MetriCide
- Primary DI
- 10615375013516
- Version / Model
- 10-602A
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- a6d1c6c6-7215-4bf8-8904-32c10d3de13e
Device Description
MetriCide OPA Plus Solution Test Strips - 60 COUNT 2 BOTTLES/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58056 | Medical device disinfection solution test strip | A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00615375013526 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 10615375013516 | GS1 | ||||
| Unit of Use | 00615375013519 | GS1 |
Customer Contacts
- Phone
- 1-800-841-1428
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241344 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage environment temperature between 59 - 86 deg F