FDA.report

OSUNG MND

Primary DI
08800075614261
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
SCGS130
Device description
A hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EGNScissors, Surgical Tissue, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075614261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075614261088000756142618800075614261

GMDN Terms

TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688207479
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
08800075628350OSUNG MNDBSF-5P2025-06-23
08800075627131OSUNG MNDSRTHD2025-04-11
08800075626714OSUNG MNDDCM010F2024-03-22
08800075626721OSUNG MNDDCM012F2024-03-22
08800075626738OSUNG MNDDCM014F2024-03-22
08800075626745OSUNG MNDDCM016F2024-03-22
08800075626752OSUNG MNDDCL010F2024-03-22
08800075626769OSUNG MNDDCL012F2024-03-22
08800075626776OSUNG MNDDCL014F2024-03-22
08800075626783OSUNG MNDDCL016F2024-03-22
08800075626790OSUNG MNDDCXL014F2024-03-22
08800075626806OSUNG MNDDCXL016F2024-03-22
08800075626813OSUNG MNDTRL010F2024-03-22
08800075626820OSUNG MNDTRL012F2024-03-22
08800075626837OSUNG MNDTRL014F2024-03-22
08800075626844OSUNG MNDTRXL012F2024-03-22
08800075626851OSUNG MNDTRXL014F2024-03-22
08800075626868OSUNG MNDPSM019C2024-03-22
08800075626875OSUNG MNDFBL019EF2024-03-22
08800075626882OSUNG MNDFBL025F2024-03-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382S3797050Surgical DirectSurgical Direct, Inc.EGN2026-03-09
B382S9038721000Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD9038721050Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD90390415L0Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD92011811070Surgical DirectSurgical Direct, Inc.EGN2026-03-02
G1493803706TBS DentalACME ENTERPRISE.EGN2026-03-02
G1493806507TBS DentalACME ENTERPRISE.EGN2026-03-02
B382S3488110Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD903220230Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD9032161010Surgical DirectSurgical Direct, Inc.EGN2026-02-20
B382SD9035171020Surgical DirectSurgical Direct, Inc.EGN2026-02-16
B382SD9036541000Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398411L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398511L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382S37921050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382S37921060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD59240Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720800Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720820Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6780830Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD80840Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9035401000Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90378310040Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90390214LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90391117LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9039831060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095200Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095230Surgical DirectSurgical Direct, Inc.EGN2026-02-03
D9283001200SCISSORS METZ 5 3/4" CRV DELICATE TCW.H. Holden, Inc.EGN2026-01-06