AccessGUDID - DEVICE: LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mm (00840117335035)

GUDID

Device Identifier (DI) Information

Brand Name: LabChoice Culture Tubes,With Dual Position Cap, Polystyrene Peel Pack,12 x 75mm
Version or Model: 42305
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117335035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: With Graduated Markings

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":	Yes
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?
14189	Culture tube	A sterile glass or plastic tube-like container used to hold a culture specimen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJG	Tube, Tissue Culture

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: bc4b3477-d1e5-4a8f-b555-8c06125f81e7
Public Version Date: March 11, 2025
Public Version Number: 1
DI Record Publish Date: March 03, 2025