FDA UDI
In Commercial Distribution
🇺🇸 United States
EXENT® Disposable MALDI plate pack
DI: 05051700020688
·
Model: IK819
·
THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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
- EXENT® Disposable MALDI plate pack
- Primary DI
- 05051700020688
- Version / Model
- IK819
- Company Name
- THE BINDING SITE GROUP LIMITED
- Labeler DUNS
- 347045614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-27
- Public Version
- 1
- Public Version Date
- 2025-12-05
- Public Version Status
- New
- Public Device Record Key
- 8c1735df-ec75-463e-8dd2-0e1abf493f69
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64071 | Mass spectrometry specimen target IVD, single-use | A flat plate intended to be used during in vitro diagnostic procedures for specimen preparation and analysis by mass spectrometry [e.g., matrix-assisted laser desorption/ionization (MALDI) mass spectrometry]. Also known as a MALDI plate, it is made of ceramic materials with individual spots or wells onto which the specimens are dispensed; some types may have an identification barcode on the surface. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051700020688 | GS1 |
Customer Contacts
- Phone
- +441214569500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius