NEEDLES 23x1

Basic Information

• Brand Name: NEEDLES 23x1
• Primary DI: 00369771001815
• Version / Model: 11-231
• Company Name: GERI-GENTLE CORPORATION
• Labeler DUNS: 361663839
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-01
• Public Version: 2
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: f84e24a5-0e1f-40e4-87fa-f1647985fd7b

Device Description

NEEDLES 23x1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36280	Medication cartridge syringe, safety-needle	A sterile device consisting of a breech-loading metal barrel with plunger into which a hermetically-sealed glass cartridge containing medication is intended to fit. The device uses an attached protective recessed or shielded needle for hypodermic drug 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	00369771001822	GS1	Inner	100	In Commercial Distribution
Primary	00369771001815	GS1

Premarket Submissions

Submission Number	Supplement Number
K193526	000