FDA.reportPublic FDA data

Munce

Primary DI
00850051045600
Brand
Munce
Company
Cjm Engineering, Inc.
Model
BK1M14
Catalog number
NA
Device description
Bur Block- platform holes marked- 14 burs: 31mm 1/4, 1/2, 1, 2, 3, 4 &#6 Cariesectomy; 34mm 1/4, 1/2, 1, 2, 3, 4 & TruGrit
Published
2024-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental
EJLBur, Dental
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1
EJLBur, DentalDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051045600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051045600008500510456008500510456000850051045600

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (805) 962-5532CUSTOMERSERVICE@CJMENGINEERING.COM

Regulatory Flags#

DUNS number
010542525
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051045624Munce18MKitNA2024-07-19
00850051045631Munce18UKitNA2024-07-19
00850051045648Munce18MBBNA2024-07-19
00850051045655Munce18UBBNA2024-07-19
00850051045662Munce18RFNA2024-07-19
00850051045006MunceBBM14NA2024-02-20
00850051045013MunceBBU142024-02-20
00850051045143Munce28GRY12024-02-20
00850051045150Munce28PUR1NA2024-02-20
00850051045167Munce28WHT12024-02-20
00850051045174Munce28YEL1NA2024-02-20
00850051045198Munce28YEL6NA2024-02-20
00850051045204Munce28YEL4NA2024-02-20
00850051045211Munce28WHT6NA2024-02-20
00850051045228Munce28WHT4NA2024-02-20
00850051045235Munce28PUR62024-02-20
00850051045242Munce28PUR42024-02-20
00850051045259Munce28GRY6NA2024-02-20
00850051045266Munce28GRY4NA2024-02-20
00850051045594MunceBK1U142024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
D661R100699C1AlpenCOLTENE/WHALEDENT INCEJL2026-06-05
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
D8120513291BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
D8120513301BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
00887919227335Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
00887919317036Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535029468Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029499Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029529Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029550Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029581Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029611Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029642Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029673Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029703Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029734Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029765Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27