Super View® Pack, Pivot Plus (40101+40227)

Basic Information

• Brand Name: Super View® Pack, Pivot Plus (40101+40227)
• Primary DI: 00852475007080
• Version / Model: 40229
• Catalog Number: 40229
• Company Name: OCULUS SURGICAL INC
• Labeler DUNS: 015409582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 0946f9c8-d5ab-4d94-96ca-083745cac348

Device Description

1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRO	General Surgery Tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47946	Ophthalmic diagnostic condensing lens	An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852475007080	GS1
Package	00852475007097	GS1	Case	8	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius