FDA UDI
In Commercial Distribution
🇺🇸 United States
HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)
DI: 03607360043899
·
Model: 4389
·
SEBIA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)
- Primary DI
- 03607360043899
- Version / Model
- 4389
- Catalog Number
- 4389
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-08
- Public Version
- 1
- Public Version Date
- 2026-01-16
- Public Version Status
- New
- Public Device Record Key
- 4617205b-e545-4838-ba86-03f077d83899
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | Immunology | 866.5510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53967 | Protein electrophoresis IVD, kit, electrophoresis | A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607360043899 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile-Handle with Care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Contact with Water
- Type
- Special Storage Condition, Specify
- Special Conditions
- This Way Up
- Type
- Special Storage Condition, Specify
- Special Conditions
- Consults Instructions for Use , Logo GHS06