Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660083076
• Version / Model: 6280E
• Catalog Number: 6280E
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f5df79db-6cee-4ad9-bdc6-7886315e5de4

Device Description

Honan balloon 1 box of 12 disposable bellows and headband (latex free), silicone tubing, gauge (latex free bulb), and case

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
LCC	Applicator, ocular pressure	Ophthalmic	886.4610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15048	Intraocular pressure-reducing system	An assembly of manually-operated devices designed to reduce the intraocular pressure (IOP), i.e., internal pressure of the eye fluids, by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. It typically consists of a headband with an attached inflatable bellows that applies pressure, an air pump (e.g., a squeeze bulb), a pressure indicator (e.g., a manometer), and tubing. It is typically used prior to surgery to induce a temporary reduction of the IOP creating a condition known as "soft surgical eye", which helps in the prevention of haemorrhaging thus reducing the risk of a surgical procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660083076	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K820526	000