FDA.reportPublic FDA data

Sinus Kit

Primary DI
08806343906571
Brand
Sinus Kit
Company
Shinhung MST Co., Ltd.
Model
SIDR2802
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
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343906571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343906571088063439065718806343906571

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806343926302Sinus KitSLD27S2026-07-29
08806343926319Sinus KitSLD32S2026-07-29
08806343926326Sinus KitSLD37S2026-07-29
08806343926333Sinus KitSLD42S2026-07-29
08806343926340Sinus KitSLD27L2026-07-29
08806343926357Sinus KitSLD32L2026-07-29
08806343926364Sinus KitSLD37L2026-07-29
08806343926371Sinus KitSLD42L2026-07-29
08806343903020Sinus KitSKRP322020-07-17
08806343903037Sinus KitSKRP372020-07-17
08806343903044Sinus KitSKRP422020-07-17
08806343903051Sinus KitSIDR202020-07-17
08806343903068Sinus KitSIDR272020-07-17
08806343903075Sinus KitSIDR322020-07-17
08806343903082Sinus KitSIDR372020-07-17
08806343903099Sinus KitSIDR422020-07-17
08806343906588Sinus KitSIDR28032020-07-17
08806343906595Sinus KitSIDR28042020-07-17
08806343906601Sinus KitSITD75032020-07-17
08806343912961MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2202026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
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06942686761407DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
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06942686761421DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761438DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761445DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761452DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761469DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761476DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21