FDA.reportPublic FDA data

Thompson

Primary DI
00841536147162
Brand
Thompson
Company
Thompson Surgical Instruments, Inc.
Model
51000ACF
Device description
Anterior Cervical Frame Tray
Published
2025-12-09
Public version status
Update
Distribution status
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
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
00841536147162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841536147162008415361471628415361471620841536147162

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2314995681gabrielle.chimner@thompsonsurgical.com

Regulatory Flags#

DUNS number
081334746
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00385640092456INSTRUSAFESummit Medical, Inc.KCT2026-08-07