FDA.report

OSUNG MND

Primary DI
08800075603449
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RDPL1
Device description
A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissors-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.
Published
2024-02-23
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
EJGForceps, Rubber Dam Clamp

Product Code Classifications

CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075603449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075603449088000756034498800075603449

GMDN Terms

TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. 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

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08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151067BL Clamp B& L Biotech, inc.EJG2025-07-18
07899798207721QuinelatoSchobell Industrial LtdaEJG2025-02-27
00889813063583Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEJG2024-11-30
00348783001488Premier Rubber Dam PunchPREMIER DENTAL PRODUCTS COMPANYEJG2024-08-01
00813677023315PDT, Inc.PDT, INC.EJG2024-06-27
00813677023322PDT, Inc.PDT, INC.EJG2024-06-27
00348783010602Premier Rubber Dam ClampPREMIER DENTAL PRODUCTS COMPANYEJG2024-04-10
D9495000821Bioclear InstrumentBioclear Matrix SystemsEJG2024-04-05
08964003163532NivoB. Ali ImpexEJG2024-01-29
08964003163600Doctor NiceB. Ali ImpexEJG2024-01-29
08964003163273NivoB. Ali ImpexEJG2024-01-27
D9495000813Bioclear InstrumentBioclear Matrix SystemsEJG2023-09-11
D9495000811Bioclear InstrumentBioclear Matrix SystemsEJG2023-08-10
05055382843894DentalTIMESCO HEALTHCARE LIMITEDEJG2023-07-06
00840105222866ZOLL DENTALZoll-DentalEJG2023-04-20
07630392900393HysolateDent4You AGEJG2023-02-28
EZPF19010000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19037010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19125000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
07898506811823QuinelatoSchobell Industrial LtdaEJG2022-10-24
00810060722541Rubber dam forceps Berman Instruments LLCEJG2022-09-21
00810038090429Composi-Tight®GARRISON DENTAL SOLUTIONS, L.L.C.EJG2022-08-31
00840105217893ZOLL-DENTALZoll-DentalEJG2021-03-10