Model: BL3124
Catalog: BL3124
DI: 10757770529206
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
PHACO ACC PK 2.4MM SLEEVE 6/BX
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b340d254-fd4d-4e11-a862-028a1568877f
Distribution Status:
In Commercial Distribution
DUNS Number:
196603781
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10757770529206
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36215
Name: Phacoemulsification system handpiece tip, single-use
Definition:
A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.
FDA Product Codes
HQC
Unit, Phacofragmentation