FDA.reportPublic FDA data

Tecomet

Primary DI
00818069017521
Brand
Tecomet
Company
TECOMET INC.
Model
CR201002-AC
Device description
Curette, Straight #5-0 Cervical, Cool Gray
Published
2020-10-07
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
HTFCurette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818069017521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818069017521008180690175218180690175210818069017521

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
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08806395489862PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
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07898506853809QuinelatoSchobell Industrial LtdaHTF2023-01-09
EZPF41891040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-16
EZPF4185501ZS0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-08
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