FDA.reportPublic FDA data

Sinus Kit

Primary DI
08806343903013
Brand
Sinus Kit
Company
Shinhung MST Co., Ltd.
Model
SHSC
Device description
Sinus Currette set
Published
2021-09-14
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
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
08806343903013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343903013088063439030138806343903013

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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

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
08806343925183ever KITEVERK2025-07-28
08806343925213TAPER KITEVERKC2025-07-28
08806343925220GUIDE KITEGKC2025-07-28
08806343925237evertisMRTN2025-07-28
08806343925244evertisMRTR2025-07-28
08806343925466evertisSSD22072025-07-28
08806343925473evertisSSD22082025-07-28
08806343925480evertisSSD22102025-07-28
08806343925497evertisSSD22112025-07-28
08806343925503evertisSSD22132025-07-28
08806343925510evertisSSD22152025-07-28
08806343925527evertisNCB502025-07-28
08806343925534evertisNSSD35072025-07-28
08806343925541evertisNSSD35082025-07-28
08806343925558evertisNSSD35102025-07-28
08806343925565evertisNSSD35112025-07-28
08806343925572evertisNSSD35132025-07-28
08806343925589evertisNSSD35152025-07-28
08806343925596evertisNSSD40072025-07-28
08806343925602evertisNSSD40082025-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESAM14447011STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447021STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447031STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447041STOMA®Storz am Mark GmbHEMJ2026-05-26
G149TBSB71010TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7720TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7730TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7740TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7750TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7760TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7770TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7780TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7790TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7800TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7810TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7820TBS BASICSACME ENTERPRISE.EMJ2026-05-22
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02