Kaiser Permanente Kit Pack

Basic Information

• Brand Name: Kaiser Permanente Kit Pack
• Primary DI: 00845819006214
• Version / Model: KP-4707-SP, B-KP-4707-SP
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: ab5653af-e4f7-43f0-957c-84c9486d8a58

Device Description

Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 3 eaches of Anterior Chamber Cannula, 27g x 7/8", 6mm Bend (GTIN: 00845819001462) 1 eaches of Irrigating Cystotome, Formed 27g x 5/8" (GTIN: 00845819006078) 1 eaches of A/C Washout Cannula, 19g x 1", 8mm Bend, Flattened (GTIN: 00845819001592) 1 eaches of Hydrodissection Cannula, 27g x 3/4”, 1mm Bend (GTIN: 00845819001530)

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZG	Surgical Eye Tray	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46840	Ophthalmic cannulation set, single-use	A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10845819006211	GS1	Carton	20	In Commercial Distribution
Primary	00845819006214	GS1

Customer Contacts

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