AccessGUDID - DEVICE: Crosstex International (10732224000395)

GUDID

Device Identifier (DI) Information

Brand Name: Crosstex International
Version or Model: CST060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CST060
Company Name: CROSSTEX INTERNATIONAL, INC.

Primary DI Number: 10732224000395
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 057728685 *Terms of Use

Device Description: ConFirm™ Premium Test Service Mail-in Sterilizer Indicators Monitoring Service, 6 Tests(3 Strip Test, 2 Tests & 1 Control Strip)

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?
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRC	Indicator, biological sterilization process

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: b0d66c91-7704-46f0-8366-7d530273ca81
Public Version Date: March 25, 2024
Public Version Number: 3
DI Record Publish Date: September 04, 2019