PPT MICS 6/BX

Basic Information

• Brand Name: PPT MICS 6/BX
• Primary DI: 04058935000646
• Version / Model: PPT049
• Catalog Number: PPT049
• Company Name: Bausch & Lomb GmbH
• Labeler DUNS: 342397433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 3
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 9dac865c-777c-467f-a0b5-4737c9f10de7

Device Description

Single Use Medical Device for Ophthalmic Surgery

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
OJK	Eye Tray	Ophthalmic	886.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04058935000646	GS1
Unit of Use	24058935000640	GS1