AccessGUDID - DEVICE: Sensititre (M578GPALL1F2)

GUDID

Device Identifier (DI) Information

Brand Name: Sensititre
Version or Model: GPALL1F
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED

Primary DI Number: M578GPALL1F2
Issuing Agency: HIBCC
Commercial Distribution End Date: March 28, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 298203498 *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?
63869	Multiple antibacterial susceptibility testing kit IVD	A collection of reagents and other associated materials containing a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection), that may be impregnated on individual testing discs or in a strip format, intended to be used to determine the antibacterial susceptibility profile of a specific bacterial microorganism (excluding mycobateria), in a clinical specimen and/or culture isolate.	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 [?]
K073558	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: 36abb310-278f-468b-b181-d4d752dfacd5
Public Version Date: March 31, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016