Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660205652
• Version / Model: Bimanual aspiration unibody handpiece
• Catalog Number: 7676T
• 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: 046ef625-cd6c-4fcd-b763-bafce2b81fe7

Device Description

Bimanual aspiration unibody handpiece, 4'', 21 gauge, curved shaft, 0.3mm aspiration port, sandblasted, titanium

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
KYG	Device, irrigation, ocular surgery	Ophthalmic	886.4360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660205652	GS1

Customer Contacts

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