AccessGUDID - DEVICE: Liofilchem Antibiotic Disc (08055182878574)

GUDID

Device Identifier (DI) Information

Brand Name: Liofilchem Antibiotic Disc
Version or Model: Ceftobiprole BPR 5 µg
Commercial Distribution Status: In Commercial Distribution
Catalog Number: $9242 Cartridge
Company Name: LIOFILCHEM SRL

Primary DI Number: 08055182878574
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435342134 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250885	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5256da96-dfb8-477e-923f-fe566c9aee65
Public Version Date: July 23, 2025
Public Version Number: 1
DI Record Publish Date: July 15, 2025