AccessGUDID - DEVICE: Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle (00850012210061)

GUDID

Device Identifier (DI) Information

Brand Name: Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle
Version or Model: SL290
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SL290
Company Name: STERILUCENT, INC.

Primary DI Number: 00850012210061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 005634969 *Terms of Use

Device Description: No description.

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 [?]
K192001	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 Humidity: between 60 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not store in direct sunlight or any other form of UV light.
Special Storage Condition, Specify: • Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2ca66ef-0e11-442e-93ac-aa833f418ece
Public Version Date: May 07, 2020
Public Version Number: 1
DI Record Publish Date: April 29, 2020