Model: RCOH62-02_0006
Catalog: RCOH62-02
DI: 10809160520338
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
08738205-7dda-4b05-bc6a-f75ecd016ee6
Distribution Status:
In Commercial Distribution
DUNS Number:
015623119
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Device ID:
10809160520338
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46408
Name: Cardiothoracic surgical procedure kit, medicated, single-use
Definition:
A collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.
FDA Product Codes
OEZ
Cardiovascular procedure kit