FDA.report

OSUNG MND

Primary DI
08800075603463
Brand
OSUNG MND
Company
OSUNG MND Co., Ltd.
Model
RDFR1
Device description
A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. 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
EJEFrame, Rubber Dam

Product Code Classifications

CodeDeviceSpecialtyClass
EJEFrame, Rubber DamDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800075603463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800075603463088000756034638800075603463

GMDN Terms

TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. 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
00813677023339PDT, Inc.PDT, INC.EJE2024-06-27
D2483553190Plast FrameHAGER WORLDWIDE, INC.EJE2024-04-16
08800075603470OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
07506338321761Nic Tone, MDC Dental MDC DENTALEJE2023-11-17
00014081053190Plast FrameHAGER WORLDWIDE, INC.EJE2023-03-27
07630392900409HysolateDent4You AGEJE2023-02-28
07630392900416HysolateDent4You AGEJE2023-02-28
07630392900423HysolateDent4You AGEJE2023-02-28
07630392900430HysolateDent4You AGEJE2023-02-28
07630392900447HysolateDent4You AGEJE2023-02-28
D24835531919Plast FrameHAGER WORLDWIDE, INC.EJE2022-12-05
07506338300582Nic Tone, MDC DentalMDC DENTALEJE2022-11-04
07506338300636Nic Tone, MDC Dental MDC DENTALEJE2022-11-03
10302731714018YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731770014YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731771011YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731776016YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731777013YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
07506338300513Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300520Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300537Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300551Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300605Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300612Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300629Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
07506338300643Nic Tone, MDC Dental MDC DENTALEJE2022-09-28
00810060723258Adult Rubber Dam Frame - 15 cmBerman Instruments LLCEJE2022-09-21
00810060723265Child Rubber Dam Frame - 13 cm Berman Instruments LLCEJE2022-09-21
07506338300650Nic Tone, MDC Dental MDC DENTALEJE2022-09-09
07506338300544NIC TONE, MDC DentalMDC DENTALEJE2022-08-30