AccessGUDID - DEVICE: Perfect Sterilization (00850048332539)

GUDID

Device Identifier (DI) Information

Brand Name: Perfect Sterilization
Version or Model: PFS-3.5-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pristine Dental Supplies, Inc.

Primary DI Number: 00850048332539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 080057154 *Terms of Use

Device Description: 3.5 X 10" Sterilization Pouches - SELF SEALING AND COLOR CHANGING 200 PER BOX 1O BOXES PER CASE

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?
60908	Sterilization container liner	A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization
JOJ	Indicator, Physical/Chemical 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: 4088b152-2c4c-4436-b97f-cb5584142bcd
Public Version Date: March 27, 2023
Public Version Number: 1
DI Record Publish Date: March 18, 2023