FDA.reportPublic FDA data

Tools - AFS

Primary DI
00842188129773
Brand
Tools - AFS
Company
Trimed, INC.
Model
AFS-HEX3.2C
Catalog number
AFS-HEX3.2C
Device description
HEX3.2C Screw Caddy
Published
2025-07-22
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
K251134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251134000RipCordTriMed, Inc.2025-07-11HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188129773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188129773008421881297738421881297730842188129773

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
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188100864Locking PlatesPS12PS122016-09-07
00842188100871Locking PlatesPS15PS152016-09-07
00842188100895Hook PlatesHOOK-4HOOK-42016-09-07
00842188100901Hook PlatesHOOK-6HOOK-62016-09-07
00842188100918Hook PlatesHOOK-8HOOK-82016-09-07
00842188100925Hook PlatesHOOK-10HOOK-102016-09-07
00842188100932Hook PlatesHOOK-12HOOK-122016-09-07
00842188101366SideWinder Fracture PlatesSWOL-6MSWOL-6M2016-09-07
00842188101373SideWinder Fracture PlatesSWOL-6NSWOL-6N2016-09-07
00842188101380SideWinder Fracture PlatesSWOL-6WSWOL-6W2016-09-07
00842188101397SideWinder Fracture PlatesSWOL-7MSWOL-7M2016-09-07
00842188101403SideWinder Fracture PlatesSWOL-7NSWOL-7N2016-09-07
00842188101410SideWinder Fracture PlatesSWOL-7WSWOL-7W2016-09-07
00842188101427SideWinder Fracture PlatesSWOR-6MSWOR-6M2016-09-07
00842188101434SideWinder Fracture PlatesSWOR-6NSWOR-6N2016-09-07
00842188101441SideWinder Fracture PlatesSWOR-6WSWOR-6W2016-09-07
00842188101458SideWinder Fracture PlatesSWOR-7MSWOR-7M2016-09-07
00842188101465SideWinder Fracture PlatesSWOR-7NSWOR-7N2016-09-07
00842188101472SideWinder Fracture PlatesSWOR-7WSWOR-7W2016-09-07
00842188101489Locking PlatesSMTP-3SMTP-32016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095044INSTRUSAFESummit Medical, Inc.KCT2026-10-13
04255858312607HIP TRIAL TRAYHermann Müller Medizintechnik GmbHKCT2026-10-13
04255858312614HIP/ KNEE TRIAL TRAY LIDHermann Müller Medizintechnik GmbHKCT2026-10-13
04255858312638KNEE TRIAL TRAYHermann Müller Medizintechnik GmbHKCT2026-10-13
G476STER16X525X15SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-13
G476STER20X10X3SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-13
00643169236967n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236974n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236981n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00385640094887INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00385640094894INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00190776436193MillenniumAvalign Technologies, Inc.KCT2026-10-08
00385640094870INSTRUSAFESummit Medical, Inc.KCT2026-10-08
00385640094832INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094849INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094856INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094863INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094801INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01