Kitazato OPU Needle with Connection Tube, Type2-v12

Basic Information

• Brand Name: Kitazato OPU Needle with Connection Tube, Type2-v12
• Primary DI: 04580303269824
• Version / Model: 328001 Type2-v12
• Catalog Number: 328001
• Company Name: KITAZATO CORPORATION
• Labeler DUNS: 711091157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-01
• Public Version: 6
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 18640f6c-0e6e-46fb-a495-bc6f9bd96b31

Device Description

18G350mm, L Stopper

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MQE	NEEDLE, ASSISTED REPRODUCTION	Obstetrics/Gynecology	884.6100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14580303269821	GS1		10	Not in Commercial Distribution	2023-01-18
Primary	04580303269824	GS1

Premarket Submissions

Submission Number	Supplement Number
K162881	000