Green Sprouts

Basic Information

• Brand Name: Green Sprouts
• Primary DI: 00715418091143
• Version / Model: 222392-906-33
• Catalog Number: 222392
• Company Name: O2cool, LLC
• Labeler DUNS: 004603413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: fddab2c4-272c-4666-b955-c97ed686e514

Device Description

Cool Hand Teether 2pk-Boy's Set-3mo+

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKO	Ring, Teething, Fluid-Filled	Dental	872.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44272	Teething device, fluid-filled	A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30715418091144	GS1	Carton	2	In Commercial Distribution
Package	20715418091147	GS1	Poly Bag	6	In Commercial Distribution
Primary	00715418091143	GS1
Unit of Use	10715418091133	GS1

Premarket Submissions

Submission Number	Supplement Number
K093370	000