FDA.reportPublic FDA data

JEDMED

Primary DI
M63342818510
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
42-8185-1
Catalog number
42-8185-1
Device description
TEETH PROTECTOR METAL SZ 1 SMALL
Published
2023-02-24
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

Product Codes#

Code, Name table
CodeName
BRWProtector, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M63342818510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
092987189
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6332904600JEDMED29-046029-04602022-12-19
M6335824200JEDMED58-242058-24202023-01-19
M6334942100JEDMED49-421049-42102016-12-14
M6334942130JEDMED49-421349-42132016-12-14
M6334942170JEDMED49-421749-42172016-12-14
M6334942200JEDMED49-422049-42202016-12-14
M6334942230JEDMED49-422349-42232016-12-14
M6334942270JEDMED49-422749-42272016-12-14
M6334943000JEDMED49-430049-43002016-12-14
M6334943030JEDMED49-430349-43032016-12-14
M633494303A0JEDMED49-4303 A49-4303 A2016-12-14
M6334943040JEDMED49-430449-43042016-12-14
M6334943070JEDMED49-430749-43072016-12-14
M6334943100JEDMED49-431049-43102016-12-14
M633494310W0JEDMED49-4310 W49-4310 W2016-12-14
M6334943130JEDMED49-431349-43132016-12-14
M633494313A0JEDMED49-4313 A49-4313 A2016-12-14
M633494313W0JEDMED49-4313 W 49-4313 W2016-12-14
M6334943170JEDMED49-431749-43172016-12-14
M6334944100JEDMED49-441049-44102016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11
10630094199013Bioseal Inc.BIOSEALBRW2023-12-07
10630094199112Bioseal Inc.BIOSEALBRW2023-12-07
10630094199129Bioseal Inc.BIOSEALBRW2023-12-07
10630094199136Bioseal Inc.BIOSEALBRW2023-12-07
08800017900599EZ Bite blockDXM CO., LTDBRW2023-07-26
10889483231135SunMedSUNMED, LLCBRW2023-07-18
00723896020210FlexiProp Reusable Mouth Prop 2 PK Small PRACTICON, INC.BRW2023-06-08
00723896020241FlexiProp Reusable Mouth Prop 2 PK Medium PRACTICON, INC.BRW2023-06-08
00723896020272FlexiProp Reusable Mouth Prop 2 PK LargePRACTICON, INC.BRW2023-06-08
M63342818520JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818530JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-09
M63342818500JEDMEDJEDMED INSTRUMENT COMPANYBRW2023-05-03
D72310297450Safco Mouth PropsSAFCO DENTAL SUPPLY CO.BRW2022-11-30