Model: EDKN-002001
DI: 06973141950173
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3969a38c-4e96-4286-a9ea-25a55ddba043
Distribution Status:
In Commercial Distribution
DUNS Number:
705006876
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
Yes
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Device ID:
06973141950173
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61204
Name: Endoscope lens cleaner, gas/fluid, single-use
Definition:
A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.
FDA Product Codes
OCX
Endoscopic Irrigation/Suction System
Premarket Submissions
Submission Number:
K221310
Supplement Number:
000