FDA.reportPublic FDA data

Tecomet

Primary DI
00841435108288
Brand
Tecomet
Company
TECOMET INC.
Model
910080
Device description
ARTHROPASSER 45° LEFT
Published
2020-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841435108288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841435108288008414351082888414351082880841435108288

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic suturing unitA manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078749695
Device count
1
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
00818069011031TecometRS1010062023-08-10
00818069011048TecometRS1010072023-08-10
00818069011055TecometRS1010082023-08-10
00818069011062TecometRS10205912023-08-10
00818069011079TecometRS10207872023-08-10
00818069011086TecometRS10209842023-08-10
00818069011093TecometRS10211812023-08-10
00818069011109TecometRS10213782023-08-10
00818069011116TecometRS10215752023-08-10
00841435111226TecometRS1010092020-10-09
00841435120365TecometRS1010102022-10-03
00818069014858TecometRS1010052020-10-09
00841435100688TecometRS1010112020-10-09
00841435100695TecometRS1010142020-10-09
00818069014339TecometRS1010062020-08-20
00818069014346TecometRS1010072020-08-20
00818069014353TecometRS1010082020-08-20
00818069014360TecometRS10205912020-08-07
00818069014377TecometRS10207872020-08-07
00818069014384TecometRS10209842020-08-07

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Primary DI, Brand, Company table
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00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
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