AccessGUDID - DEVICE: Trinity Biotech (05391516742238)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 591-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 591-C
Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY

Primary DI Number: 05391516742238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 988298840 *Terms of Use

Device Description: Oxalate Kit

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
53503	Oxalate IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of oxalate in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPW	System, Test, Oxalate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K883525	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Tests

Device Record Status

Public Device Record Key: b307a2b3-823e-4337-8805-e8725dec16f1
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: October 06, 2017