FDA.reportPublic FDA data

OSUNG MND

Primary DI
08800075627728
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RGCPD
Device description
A freestanding container with an opening designed to hold and dispense dressings (including swabs and bandages) in discrete quantities (e.g., one at a time) at the point of use. It is typically a plastic or metal container with a lid to allow loading of the dressings, and a separate port to allow easy retrieval of the dressings. It is used in settings such as an examination room, a doctor's surgery, or where surgical procedures are performed in the hospital. This is a reusable device.
Published
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075627728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075627728088000756277288800075627728

GMDN Terms#

Term, Definition table
TermDefinition
Dressing dispenserA freestanding container with an opening designed to hold and dispense dressings (including swabs and bandages) in discrete quantities (e.g., one at a time) at the point of use. It is typically a plastic or metal container with a lid to allow loading of the dressings, and a separate port to allow easy retrieval of the dressings. It is used in settings such as an examination room, a doctor's surgery, or where surgical procedures are performed in the hospital. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688207479
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800075629524OSUNG MNDBSF-BHCL2026-05-14
08800075629531OSUNG MNDBSF-5P-BHCL2026-05-14
08800075628749OSUNG MNDCRP019EF2026-04-01
08800075628756OSUNG MNDFBL0192026-04-01
08800075628763OSUNG MNDRP015EF2026-04-01
08800075628770OSUNG MNDCRP019SF2026-04-01
08800075628787OSUNG MNDFBL019SF2026-04-01
08800075628794OSUNG MNDRP015SF2026-04-01
08800075628800OSUNG MNDCIS0122026-04-01
08800075628817OSUNG MNDCIS013F2026-04-01
08800075628824OSUNG MNDCIS0162026-04-01
08800075628831OSUNG MNDCISS0132026-04-01
08800075628848OSUNG MNDCISS0162026-04-01
08800075628855OSUNG MNDDCM009F2026-04-01
08800075628862OSUNG MNDDCXL018F2026-04-01
08800075628879OSUNG MNDDCXXL014F2026-04-01
08800075628886OSUNG MNDFBL0232026-04-01
08800075628893OSUNG MNDFBL0252026-04-01
08800075628909OSUNG MNDFSM0102026-04-01
08800075628916OSUNG MNDFSS009F2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14