Device
5MM, 33CM, HUNTER DEBAKEY, FENESTRATED, 20MM , INSERT ONLY
Manufacturer
ELMED INCORPORATED
ELMED INCORPORATED
Model: 52255-58I
Catalog: 52255-58I
DI: 00198506090592
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
5MM, 33CM, HUNTER DEBAKEY, FENESTRATED, 20MM , INSERT ONLY
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:
7a43feb7-383e-4f17-b769-5341d021a7c7
Distribution Status:
In Commercial Distribution
DUNS Number:
049290364
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:
00198506090592
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32043
Name: Laparoscopic surgical procedure kit, non-medicated, reusable
Definition:
A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.
FDA Product Codes
GCJ
Laparoscope, General & Plastic Surgery
Premarket Submissions
Submission Number:
K181173
Supplement Number:
000