FDA.reportPublic FDA data

Sinus Kit

Primary DI
08806343906588
Brand
Sinus Kit
Company
Shinhung MST Co., Ltd.
Model
SIDR2803
Device description
Sinus Kit consists of drills & Instruments used for maxillary sinus elevation by crestal & lateral approach.
Published
2020-07-17
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
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343906588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343906588088063439065888806343906588

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275549Intrace USAPILOTIS TECH LLCEMJ2026-07-03
00810189451216Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451223Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451230Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451247Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451254Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451261Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451278Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451285Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451292Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451308Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451315Surgical DesignSurgical Design, Inc.EMJ2026-06-06
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G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7670TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7680TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7690TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7700TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7710TBS BASICSACME ENTERPRISE.EMJ2026-05-21