Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660105013
• Version / Model: Kellen capsulorhexis marker
• Catalog Number: 8892E
• 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: 2
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 79b32a85-bd31-47cb-9674-b14d9fd6505d

Device Description

Kellen capsulorhexis marker, 4'', 6.0mm diameter ring, with 2.5mm alignment extension bars, 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
HMR	Marker, ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42367	Scleral marker, reusable	A manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer material. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660105013	GS1

Customer Contacts

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