FDA.reportPublic FDA data

OSUNG MND

Primary DI
08800075627711
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RGCP1
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
08800075627711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075627711088000756277118800075627711

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
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
05397311032789Driver Hex 0.9 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032796Driver Hex 1.2 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032802Driver Hex 1.3 mmHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032819Angled DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032833SCS DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032840Unigrip DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032857Multi-Unit DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032864FlexDrive® Aluminium Tray PHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032895Driver BioHorizons 4.5HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032901Driver BioHorizons 5.7HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26