Device
Helveston Muscle Hook, Extra Delicate Blunt Tip Tip 8mm OL 130mm (5")
Manufacturer
Avalign Technologies, Inc.
Avalign Technologies, Inc.
Model: 92-H07308
DI: 00190776420833
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Helveston Muscle Hook, Extra Delicate Blunt Tip Tip 8mm OL 130mm (5")
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:
64489125-c8ec-4d00-b0d8-0574a51ccefd
Distribution Status:
In Commercial Distribution
DUNS Number:
792528510
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:
00190776420833
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12036
Name: Eye muscle hook, reusable
Definition:
A hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. This is a reusable device.
FDA Product Codes
HNQ
Hook, Ophthalmic