FDA.report

S-Guide Kit

Primary DI
08806343919151
Brand
S-Guide Kit
Company
Shinhung MST Co., Ltd.
Model
AD10
Device description
Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient and safe surgery with minimal error and drill heating.
Published
2021-04-13
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

Related Records

Contact Domains

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806343919151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806343919151088063439191518806343919151

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415271Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792170Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792187Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792194Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792200Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792217Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792224Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792231Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792248Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792255Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792279Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20