Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 10190660199392
• Version / Model: Nucleus rotator
• Catalog Number: 195077
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: fa95e6fe-dbd6-464d-b3e1-7860666b115e

Device Description

Nucleus rotator, angled, Y-shaped tip, packaged individually, sterile, disposable, box of 3 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 10 BOXES AND 4-6 WEEK LEAD TIME * *

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNQ	Hook, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12036	Eye muscle hook, reusable	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00190660199395	GS1	BX	3	In Commercial Distribution
Primary	10190660199392	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]