Model: IN-2600-04-EN-085
DI: 00385640091893
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
facd396c-dcb4-4a99-89df-81b265e6bb96
Distribution Status:
In Commercial Distribution
DUNS Number:
965484699
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00385640091893
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12143
Name: Instrument tray, reusable
Definition:
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
FDA Product Codes
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Premarket Submissions
Item #1 - Submission Number:
K051157
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K133015
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K140289
Item #3 - Supplement Number:
000
Item #4 - Submission Number:
K141513
Item #4 - Supplement Number:
000
Item #5 - Submission Number:
K142630
Item #5 - Supplement Number:
000
Item #6 - Submission Number:
K142768
Item #6 - Supplement Number:
000
Item #7 - Submission Number:
K150540
Item #7 - Supplement Number:
000
Item #8 - Submission Number:
K151166
Item #8 - Supplement Number:
000
Item #9 - Submission Number:
K210836
Item #9 - Supplement Number:
000