FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraCrit™ Cleaning Tools
DI: 00831829000342
·
Model: 320-111
·
SEPARATION TECHNOLOGY, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- UltraCrit™ Cleaning Tools
- Primary DI
- 00831829000342
- Version / Model
- 320-111
- Catalog Number
- 320-111
- Company Name
- SEPARATION TECHNOLOGY, INC.
- Labeler DUNS
- 195501127
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-08-25
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c4b43731-afc3-4892-a46b-0c462d7e131e
Device Description
UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59059 | Wash/cleaning solution IVD, manual equipment | A wash or cleaning solution intended to be used in the preparation, decontamination and/or cleanup of equipment (e.g., glassware, weighing equipment) used for the manual processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00831829000342 | GS1 | ||||
| Unit of Use | 00831829000359 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]