FDA.reportPublic FDA data

Tecomet

Primary DI
00818069018498
Brand
Tecomet
Company
TECOMET INC.
Model
RC404023-A
Device description
Hand Held Rod Cutter, End Cutter 5.5 Collapsible Short Ortho-Grip™, Black
Published
2020-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00818069018498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818069018498008180690184988180690184980818069018498

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078749695
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818069012915Tecomet3741062023-07-23
00841435109810TecometSR131000-E2026-05-11
00841435111264TecometDB101119-A2026-05-01
00841435111288TecometDB101120-A2026-05-01
00841435124363TecometTW203060-AH2026-05-01
00818069014315TecometMA101000-A2020-08-21
00818069014476TecometSR632000-A2020-08-21
00818069013196TecometCD1020092020-08-10
00818069013226TecometCD1020122020-08-10
00818069014209TecometCD1020142020-08-10
00818069014483TecometTA1010002020-08-10
00818069014520TecometUT1010012020-08-10
00818069010225TecometCD1020022020-08-09
00818069013110TecometCD1020032020-08-09
00818069013127TecometCD1020042020-08-09
00818069014360TecometRS10205912020-08-07
00818069014377TecometRS10207872020-08-07
00818069014384TecometRS10209842020-08-07
00818069014391TecometRS10211812020-08-07
00818069014407TecometRS10213782020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7890TBS BASICSACME ENTERPRISE.FZT2026-05-21
14250368861550KURZ Precise Cartilage Knife SetHeinz Kurz GmbHFZT2026-05-21
08717903490594Humeca MAX MesherHumeca B.V.FZT2026-03-31
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
05010058080836InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
10649111400117Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400124Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400131Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
E896294920SCHWERTA. Schweickhardt GmbH & Co. KGFZT2025-05-22
05010058081987InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
05010058999749InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
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