Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660096953
• Version / Model: Lewis lens loop
• Catalog Number: 3725E
• 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: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: f9d15395-8f77-48d6-8f3a-bbad4c09f8f8

Device Description

Lewis lens loop, 5 3/8'', small, curved, smooth 5.0mm x 6.0mm loop, 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
HNE	Snare, enucleating	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13487	Enucleation scissors, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut tissue during surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660096953	GS1

Customer Contacts

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