Liofilchem Antibiotic Disc

Basic Information

• Brand Name: Liofilchem Antibiotic Disc
• Primary DI: 08058951161310
• Version / Model: Sulopenem SPM 2 µg
• Company Name: LIOFILCHEM SRL
• Labeler DUNS: 435342134
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-03
• Public Version: 1
• Public Version Date: 2025-11-11
• Public Version Status: New
• Public Device Record Key: 15f8d24d-8f1b-4182-9ea7-5c4ebe6f7e15

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
Primary	08058951161310	GS1

Premarket Submissions

Submission Number	Supplement Number
K251879	000