FDA UDI
In Commercial Distribution
🇺🇸 United States
Crosstex International
DI: 10732224000401
·
Model: CST120
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Crosstex International
- Primary DI
- 10732224000401
- Version / Model
- CST120
- Catalog Number
- CST120
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2019-09-04
- Public Version
- 2
- Public Version Date
- 2020-04-13
- Public Version Status
- Update
- Public Device Record Key
- c61db10f-7710-404c-bad0-22f25a98f114
Device Description
ConFirm™ Premium Test Service Mail-in Sterilizer Indicators Monitoring Service, 12 Tests (3 Strip Test, 2 Tests & 1 Control Strip)
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 50732224000409 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 10732224000401 | GS1 | ||||
| Unit of Use | 00732224000404 | GS1 |
Customer Contacts
- Phone
- +1(888)276-7783
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023716 | 000 |