Model: 989-9002-3
DI: 00197157056513
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
TIGER 2 IMPLANT TRAY - MODULAR HEAD CADDY
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:
f2c96143-94ef-4031-97a1-3ceae8decaba
Distribution Status:
In Commercial Distribution
DUNS Number:
069472800
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00197157056513
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
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number:
K243908
Supplement Number:
000