Device
Pace Ultra Screw Caddy, 6.0mm
Manufacturer
Pace Surgical, Inc.
Model: PS3-2000060 Catalog: PS3-2000060 DI: 00810211040067 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
Pace Ultra Screw Caddy, 6.0mm
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: 987d1b84-9ab0-4d4e-8127-03dcc0c303b3
Distribution Status: In Commercial Distribution
DUNS Number: 119302878
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810211040067
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
FSM
Tray, Surgical, Instrument