Model: 5032305U0
Catalog: 5032305U0
DI: 08404535029437
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
PACIFIC NORTHWEST INTR ZIRCONIA
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
44510cb8-2b53-4f43-9443-2e314cb3777c
Distribution Status:
In Commercial Distribution
DUNS Number:
082080136
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08404535029437
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40517
Name: Sterilization packaging, reusable
Definition:
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 reusable device.
FDA Product Codes
FRG
Wrap, sterilization
Premarket Submissions
Submission Number:
K983223
Supplement Number:
000