FDA UDI
In Commercial Distribution
🇺🇸 United States
Medicom® AssureCheck™
DI: 10686864060892
·
Model: ST1010
·
AMD Medicom Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Medicom® AssureCheck™
- Primary DI
- 10686864060892
- Version / Model
- ST1010
- Company Name
- AMD Medicom Inc
- Labeler DUNS
- 256880576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-10-14
- Public Version
- 1
- Public Version Date
- 2024-10-22
- Public Version Status
- New
- Public Device Record Key
- 4de1a4d2-b792-4ef9-9f8c-11ce42d096d4
Device Description
Medicom AssureCheck 10HR Steam Biological Indicator
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 |
|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00686864060895 | GS1 | ||||
| Primary | 10686864060892 | GS1 |
Customer Contacts
- Phone
- 1(514)636-6262
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093794 | 000 |