Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660201760
• Version / Model: Camellin style LASIK alcohol well
• Catalog Number: 2084E
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-04
• Public Version: 1
• Public Version Date: 2021-01-12
• Public Version Status: New
• Public Device Record Key: 9ac1e99c-4258-4758-bcb1-13a4a14e9c5a

Device Description

Camellin style LASIK alcohol well, 4'', 6.5mm diameter, 3.5mm high, flat handle

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNH	RING, OPHTHALMIC (FLIERINGA)	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62785	Ophthalmic surgery fluid retention ring	A sterile ophthalmic device intended to be placed on the cornea to provide a physical barrier for fluid retention of the eye during ophthalmic surgery. It is a bevelled, hollow cylinder made of high-grade stainless steel, similar in shape to a non-cutting corneal trephine, with a double-walled vacuum ring intended to create an airtight seal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660201760	GS1

Customer Contacts

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