AccessGUDID - DEVICE: Plasdent Clear Protection Sterilization Pouch (D832POH3129)

GUDID

Device Identifier (DI) Information

Brand Name: Plasdent Clear Protection Sterilization Pouch
Version or Model: POH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: POH312-9
Company Name: PLASDENT CORPORATION

Primary DI Number: D832POH3129
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 190377184 *Terms of Use

Device Description: Autoclave Pouches 3 1/2" x 9", Dual Indicator (200pcs/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?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172280	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9be8867-ab93-4423-9b7e-38d59d40ffae
Public Version Date: February 22, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
D832POH31295	2000	D832POH3129	In Commercial Distribution	case
D832POH31291	200	D832POH3129	In Commercial Distribution	box
D832POH31292	10	D832POH31291	In Commercial Distribution	Case