Surgical Kit

Primary DI
08806343902290
Brand
Surgical Kit
Company
Shinhung MST Co., Ltd.
Model
SDE00
Device description
These instruments are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Published
2020-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343902290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343902290088063439022908806343902290

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82337301900syangt8823@shinhung.co.kr
+82337301913jssong@shinhung.co.kr

Regulatory Flags#

DUNS number
689667152
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806343912961MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2202026-04-13
08806343912978MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3202026-04-13
08806343912985MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4202026-04-13
08806343912992MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5202026-04-13
08806343913005MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6202026-04-13
08806343913012MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1252026-04-13
08806343913029MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2252026-04-13
08806343913036MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3252026-04-13
08806343913043MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4252026-04-13
08806343913050MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5252026-04-13
08806343913067MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6252026-04-13
08806343913074MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1302026-04-13
08806343913081MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2302026-04-13
08806343913098MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3302026-04-13
08806343913104MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4302026-04-13
08806343913111MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5302026-04-13
08806343913128MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6302026-04-13
08806343913135MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1352026-04-13
08806343913142MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2352026-04-13
08806343913159MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3352026-04-13

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