rainbow shine

Basic Information

• Brand Name: rainbow shine
• Primary DI: 08809552960327
• Version / Model: SH9816WA2
• Catalog Number: SH9816WA2
• Company Name: GENOSS CO., Ltd.
• Labeler DUNS: 690083006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-20
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 66488e31-8a3d-45e2-8951-db02f29ae8d4

Device Description

Dental ceramic

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: Yes
• 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
EIH	POWDER, PORCELAIN	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16787	Skin staple remover, reusable	A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is made of metallic or synthetic polymer materials with blades at the distal end designed for grasping, opening, and removing surgical staples. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809552960327	GS1

Premarket Submissions

Submission Number	Supplement Number
K160079	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	98	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius