FDA.reportPublic FDA data

Munce

Primary DI
00850051045594
Brand
Munce
Company
Cjm Engineering, Inc.
Model
BK1U14
Device description
Bur Block- platform holes unmarked- 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
00850051045594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051045594008500510455948500510455940850051045594

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
00850051045600MunceBK1M14NA2024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
00888867504059Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504066Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504073Arthrex®ARTHREX, INC.FSM2026-09-21
00749756400800DeRoyalDEROYAL INDUSTRIES, INC.FSM2026-09-18
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04