FDA.reportPublic FDA data

rainbow shine

Primary DI
08809552960358
Brand
rainbow shine
Company
GENOSS CO., Ltd.
Model
SH9818WA2
Catalog number
SH9818WA2
Device description
Dental ceramic
Published
2017-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160079000rainbow ShineGenoss Co., Ltd.2016-11-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809552960358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809552960358088095529603588809552960358

GMDN Terms#

Term, Definition table
TermDefinition
Skin staple remover, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter98Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690083006
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026544722Implant Guide Kit GIGK2024-07-19
08800026544739Implant Guide Kit GGD26292024-07-19
08800026544746Implant Guide Kit GGD26352024-07-19
08800026544753Implant Guide Kit GMG22024-07-19
08800026544760Implant Guide Kit GSP052024-07-19
08800026544777Implant Guide Kit GSP072024-07-19
08800026544784Implant Guide Kit GSP092024-07-19
08800026544791Implant Guide Kit GSP112024-07-19
08800026544807Implant Guide Kit GGP04052024-07-19
08800026544814Implant Guide Kit GGP06072024-07-19
08800026544821Implant Guide Kit GGP08092024-07-19
08800026544838Implant Guide Kit GGP10112024-07-19
08800026501558GENOSS Inflator B30GBI-B302024-06-18
08800026501565GENOSS Inflator B30GBI-302024-06-18
08800026507598GENOSS Inflator B30GBI-B30S2024-06-18
08800026507611GENOSS Inflator B40 GBI-B40V2024-06-18
08800026507635GENOSS Inflator B40 GBI-B40VS2024-06-18
08800026512752GENOSS Inflator B40 GBI-B40S2024-06-18
08800026530329GENOSS Inflator B30GBI-B302024-06-18
08809324765433GENOSS Inflator B30GBI-30V2024-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
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06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
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