FDA.report

Surgical Simple Kit3

Primary DI
08809918273634
Brand
Surgical Simple Kit3
Company
Ossvis Co., Ltd.
Model
SSK3
Device description
Dental Implant Surgical Instrument - KIT
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OFYDental Implant Surgical Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809918273634PrimaryGS10

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
695365503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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08809918209756LW Pre-milled AbutmentLWDPA1040HDB2024-12-18
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