FDA.reportPublic FDA data

Tecomet

Primary DI
00818069019013
Brand
Tecomet
Company
TECOMET INC.
Model
LC50001
Device description
2nd Generation Evolution Lid Thoracolumbar Blank
Published
2020-10-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012105000POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMSymmetry Medical, Inc.2002-08-02KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818069019013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818069019013008180690190138180690190130818069019013

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
262-925-4531julie.davis@tecomet.com

Regulatory Flags#

DUNS number
078749695
Device count
1
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
00841435122925TecometPA0172026-08-07
00841435123717Tecomet464872026-07-30
00841435123724Tecomet464882026-07-30
00841435123731Tecomet464902026-07-30
00841435123557Tecomet463592025-02-07
00841435123564Tecomet463612025-02-07
00841435123571Tecomet463632025-02-07
00841435121355Tecomet2399-16-0002023-07-21
00818069019228TecometSR354002-A2020-10-08
00841435121621Tecomet2788-12-0002023-07-20
00841435119062Tecomet466322026-06-08
00818069019631TecometTR123000-A2020-10-09
00818069019655TecometTR123000-J2020-10-09
00818069019662TecometTR123000-Q2020-10-09
00818069019679TecometTR123000-Z2020-10-09
00818069019839TecometTR311000-J2020-10-09
00818069019969TecometTR415000-BN2020-10-09
00818069019976TecometTR415000-J2020-10-09
00818069015299TecometSR111000-A2020-10-08
00818069015305TecometSR111000-E2020-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640092166INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092173INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092180INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092197INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092203INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092210INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092227INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092234INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092241INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092258INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092265INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092272INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092289INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092296INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092302INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092319INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092326INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092333INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092340INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092357INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092364INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092371INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092388INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092395INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092401INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092418INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092425INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092432INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092449INSTRUSAFESummit Medical, Inc.KCT2026-08-07
00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07