AccessGUDID - DEVICE: ProSpore2 (M985PS2361)

GUDID

Device Identifier (DI) Information

Brand Name: ProSpore2
Version or Model: Log 6
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PS2-3-6-50
Company Name: MESA LABORATORIES, INC.

Primary DI Number: M985PS2361
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2017
Device Count: 50
Labeler D-U-N-S® Number*: 102530326 *Terms of Use

Device Description: Biological Indicator for steam sterilization (121C). Contains spores of Geobacillus stearothermophilus. 50 units / box.

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: a26cdbdb-4646-4e9c-b273-2bf7f9b96251
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 20, 2017