Barrigel Applicator Needle

Basic Information

• Brand Name: Barrigel Applicator Needle
• Primary DI: 00850004725115
• Version / Model: 3009-2
• Catalog Number: 3009-2
• Company Name: PALETTE LIFE SCIENCES, INC.
• Labeler DUNS: 116951700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2023-03-02
• Public Version Status: Update
• Public Device Record Key: 6f02f7dc-f420-4443-8df9-1553e919f883

Device Description

Barrigel applicator needle

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVB	Hydrogel Spacer	Radiology	892.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45019	Submucosal injection needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850004725115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220641	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge
Length	20	Centimeter