Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331137587
• Version / Model: OP7116-23
• Catalog Number: OP7116-23
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: e5b7a279-ae73-4716-8edb-06a45ad86621

Device Description

desmarres lid retractor, stainless, 5 1/2" (14.0 cm), size 2, 14.0 mm wide

Device Characteristics

• Single Use: Yes
• 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
HNI	Retractor, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35527	Periocular/lacrimal retractor, self-retaining	A self-retaining, ophthalmic surgical instrument intended to be used to draw aside the margins of a periocular surgical wound, typically to access the nasolacrimal duct/lacrimal sac during an ophthalmic intervention; it is not intended to retract tissues of the eyeball and is not an eyelid speculum. The instrument is typically designed with two conjoined legs and a self-retaining mechanism, and is usually made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331137587	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]