FDA.report

Tecomet

Primary DI
00818069018092
Brand
Tecomet
Company
TECOMET INC.
Model
RC302002-J
Device description
Table Top Rod Cutter, 4.76-5.50-6.35 Collapsible/Removeable Drain Hole, Blue
Published
2020-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FZTCutter, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818069018092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818069018092008180690180928180690180920818069018092

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078749695
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00841435111509Tecomet482742026-03-02
00841435120402Tecomet004808020012026-02-27
00841435122574Tecomet004803105002026-02-27
00841435124929Tecomet800-08-0182026-02-26
00841435111554TecometTLG132075-J2025-11-14
00841435124295Tecomet004816002012025-09-15
00841435124912TecometAR-9938-112025-09-05
00841435111080Tecomet465722025-08-27
00841435111103Tecomet479312025-08-27
00841435111127Tecomet482422025-08-27
00841435111134Tecomet482442025-08-27
00841435111141Tecomet482452025-08-27
00841435111158Tecomet482462025-08-27
00841435111165Tecomet482542025-08-27
00841435111172Tecomet482482025-08-27
00841435111189Tecomet482592025-08-27
00841435111202Tecomet482692025-08-27
00841435118263Tecomet004819011002025-08-27
00841435118287Tecomet004819014002025-08-27
00841435118317TecometK000-20102025-08-27

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10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
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03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
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03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
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03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
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