FDA.reportPublic FDA data

Thompson

Primary DI
00851267006010
Brand
Thompson
Company
THOMPSON SURGICAL INSTRUMENTS, INC.
Model
10050000E2L
Device description
Instrument Case Elite 2 Table Mount Lid
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K151347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151347000MIS Spine Frame Instrument CaseThompson Surgical Instruments2015-10-16KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851267006010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851267006010008512670060108512670060100851267006010

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
062475033
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841536148473Thompson10243902ACS2026-07-08
00841536101812ThompsonSL45619AT2022-08-11
00841536101379ThompsonSL45602AT2020-08-07
00841536101386ThompsonSL45603AT2020-08-07
00841536101393ThompsonSL45610AT2020-08-07
00841536101799ThompsonSL45611AT2020-08-07
00841536101805ThompsonSL45618AT2020-08-07
00841536120165ThompsonS45601Q2020-08-07
00841536120189ThompsonS45616Q2020-08-07
00841536121100ThompsonSL45600AT2020-08-07
00841536121124ThompsonSL45601AT2020-08-07
00841536121230ThompsonSL45614AT2020-08-07
00841536125511ThompsonSO45612AETT2020-08-09
00841536125528ThompsonSO45612AT2020-08-09
00841536125542ThompsonSO45613AT2020-08-09
00841536125566ThompsonSO45615AT2020-08-09
00841536125580ThompsonSO45616AT2020-08-09
00841536112610Thompson45600AT2020-08-04
00841536112634Thompson45601AT2020-08-04
00841536112658Thompson45602AT2020-08-04

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Primary DI, Brand, Company table
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00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
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07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
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