Model: 5031791U0
Catalog: 5031791U0
DI: 08404535015003
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
LYON FIXED BLOCK 9735-D 1P
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:
a159d8b7-e8fa-4906-842a-d5e656faf611
Distribution Status:
In Commercial Distribution
DUNS Number:
082080136
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
No
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:
08404535015003
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 13730
Name: Device sterilization/disinfection container, reusable
Definition:
A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.
FDA Product Codes
FRG
Wrap, sterilization
Premarket Submissions
Submission Number:
K983223
Supplement Number:
000