FDA.reportPublic FDA data

ACE

Primary DI
00614950012015
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
04994401
Catalog number
04994401
Device description
ROUND BONE CUTTING BUR 44.5TL 5HD STAINLESS STEEL 420 HP
Published
2019-10-12
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
FZTCUTTER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950012015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950012015006149500120156149500120150614950012015

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental burA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950025510ACE003293700329372019-10-24
00614950025558ACE080000208000022019-10-24
00614950025565ACE080000308000032019-10-24
00614950025572ACE080001108000112019-10-24
00614950013425ACE003105900310592019-10-16
00614950031207ACE484200248420022023-12-05
00614950031214ACE484200348420032023-12-05
00614950030149ACE20982511209825112023-12-05
00614950030927ACE45450201454502012023-12-05
00614950012831ACE90440018S90440018S2019-10-13
00614950012848ACE90440018ST90440018ST2019-10-13
00614950026272ACE90250018902500182019-10-13
00614950026289ACE90250023902500232019-10-13
00614950026296ACE90440018904400182019-10-13
00614950026302ACE90440023904400232019-10-13
00614950026319ACE90440023S90440023S2019-10-13
00614950026326ACE90440023ST90440023ST2019-10-13
00614950026333ACE90500018905000182019-10-13
00614950026340ACE90500018S90500018S2019-10-13
00614950026357ACE90500023905000232019-10-13

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Primary DI, Brand, Company table
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05010058084346InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-12-16
00192896122499Cartilage Graft CutterSONTEC INSTRUMENTS, INC.FZT2025-11-21
03662663113151Virage OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-11-12
04049197556552RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZT2025-10-15
05033955023263Swann-Morton LimitedSWANN-MORTON LIMITEDFZT2025-08-25
05010058080492InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
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E896294920SCHWERTA. Schweickhardt GmbH & Co. KGFZT2025-05-22
05010058081987InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
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10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111079092Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488115Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488122Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
05033955035266Swann Morton Ltd.SWANN-MORTON LIMITEDFZT2024-10-15
05033955036263Swann Morton Ltd.SWANN-MORTON LIMITEDFZT2024-10-15
00850037506262MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-09-18
00850037506231MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506248MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506255MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00714646000781SutureOutBionix, LLCFZT2024-04-23
00714646001184SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08