FDA UDI
In Commercial Distribution
🇺🇸 United States
Liofilchem Antibiotic Disc
DI: 08055182878574
·
Model: Ceftobiprole BPR 5 µg
·
LIOFILCHEM SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
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
- Liofilchem Antibiotic Disc
- Primary DI
- 08055182878574
- Version / Model
- Ceftobiprole BPR 5 µg
- Catalog Number
- $9242 Cartridge
- Company Name
- LIOFILCHEM SRL
- Labeler DUNS
- 435342134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-15
- Public Version
- 1
- Public Version Date
- 2025-07-23
- Public Version Status
- New
- Public Device Record Key
- 5256da96-dfb8-477e-923f-fe566c9aee65
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 |
|---|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63834 | Antibacterial susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18055182878571 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08055182878574 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250885 | 000 |