Device
Hydrodissection Cannula [Daya] Flattened, Formed 11mm
Manufacturer
Psi/Eye-Ko, Inc.
Model: 7007D DI: 00840516145839 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Hydrodissection Cannula [Daya] Flattened, Formed 11mm
Sterilization
Item #1: Radiation Sterilization
Item #2: Ethylene Oxide
Device Sterile: Yes
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 43b9d2b1-a3bf-4376-a0dd-f9668a5d2fff
Distribution Status: In Commercial Distribution
DUNS Number: 063763833
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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: Yes
Identifiers
Item #1 - Pkg Type: Box
Item #1 - Device ID: 00840516145846
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00840516145839
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840516145839
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Box
Item #3 - Device ID: 00840516145853
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 100
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 00840516145839
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 46705
Name: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Definition:
A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.
FDA Product Codes
HMX
Cannula, Ophthalmic