FDA.reportPublic FDA data

OSUNG MND

Primary DI
08800075612861
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RDPN1P
Device description
A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.
Published
2024-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMEPunch, Biopsy, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800075612861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800075612861088000756128618800075612861

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam punchA hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. 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

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