AccessGUDID - DEVICE: UTM-RT (38053326009304)

GUDID

Device Identifier (DI) Information

Brand Name: UTM-RT
Version or Model: 3C040N.HL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3C040N.HL
Company Name: COPAN ITALIA SPA

Primary DI Number: 38053326009304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 428981112 *Terms of Use

Device Description: UTM-RT KIT Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens Flexible Flocked Swab

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):	Yes
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?
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	Culture Media, Non-Propagating Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 410fe27d-8d97-4494-a9a3-f6f4cbeffef2
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022