Model: MK8510LSK
Catalog: MK8510LSK
DI: 10810003224757
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Microkeratome blade for LSK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ab46896f-3998-42fd-a990-3b144c829694
Distribution Status:
In Commercial Distribution
DUNS Number:
013469890
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 - Device ID:
10810003224757
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Box
Item #2 - Device ID:
30810003224751
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
10810003224757
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44722
Name: Keratome blade, single-use
Definition:
A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.
FDA Product Codes
HNO
Keratome, Ac-Powered
Premarket Submissions
Submission Number:
K011195
Supplement Number:
000