Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660128005
• Version / Model: Quickert lacrimal intubation probe
• Catalog Number: 9793E
• 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: f688e56f-d7a8-4597-bded-92781948fffa

Device Description

Quickert lacrimal intubation probe, 5 5/8'', double-ended, size #2, Jones-type taper point, Bowman-type blunt tip

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
HNL	Probe, lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35010	Lacrimal dilator, reusable	A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660128005	GS1

Customer Contacts

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