Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660092078
• Version / Model: Iris retractors
• Catalog Number: 5055E
• 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: c16b82be-5b7c-425b-bf56-e9a07528d36a

Device Description

Iris retractors, round, bright blue, flexible polypropylene fiber, 1 set of 6 retractors, supplied non-sterile in a steam autoclavable container, not recommended for more then 3 uses

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: Yes
• 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
HNI	Retractor, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63431	Intraocular retractor, reusable	A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660092078	GS1

Customer Contacts

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