Model: TL10
DI: 07290020744005
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-26
Current Version: 2026-05-06
Description
Endoscope Lens Cleaner
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
201a4ab7-f5da-4841-b2f6-961e639541df
Distribution Status:
In Commercial Distribution
DUNS Number:
521149674
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
17290020744002
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
6
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07290020744005
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07290020744005
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
27290020744009
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
12
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
07290020744005
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 38835
Name: Surgical instrument/endoscope cleaning utensil, single-use
Definition:
A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.
FDA Product Codes
GCJ
Laparoscope, General & Plastic Surgery
Premarket Submissions
Submission Number:
K260089
Supplement Number:
000