Model: IC-27G
DI: 00817325025010
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
Description
Nam illumination probe with chopper, 27G(0.42mm)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e95513c2-7546-418d-9806-d9c020b4bc43
Distribution Status:
In Commercial Distribution
DUNS Number:
927071162
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Inner box
Item #1 - Device ID:
10817325025017
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00817325025010
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00817325025010
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Carton box
Item #3 - Device ID:
20817325025014
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
9
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10817325025017
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 45193
Name: Ophthalmic fibreoptic light instrument, single-use
Definition:
A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.
FDA Product Codes
MPA
Endoilluminator
Premarket Submissions
Submission Number:
K202670
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
1
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature