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

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
00842188100758Locking PlatesPC6PC62016-09-07
00842188100765Locking PlatesPCA8PCA82016-09-07
00842188100772Locking PlatesPCA10PCA102016-09-07
00842188100789Locking PlatesPCA15PCA152016-09-07
00842188100796Locking PlatesPCB8PCB82016-09-07
00842188100802Locking PlatesPCB10PCB102016-09-07
00842188100819Locking PlatesPCB15PCB152016-09-07
00842188100826Locking PlatesPS5PS52016-09-07
00842188100833Locking PlatesPS6PS62016-09-07
00842188100840Locking PlatesPS8PS82016-09-07
00842188100857Locking PlatesPS10PS102016-09-07
00842188100864Locking PlatesPS12PS122016-09-07
00842188100871Locking PlatesPS15PS152016-09-07
00842188101274Hook PlatesOHOOK-4OHOOK-42016-09-07
00842188101281Hook PlatesOHOOKL-6OHOOKL-62016-09-07
00842188101298Hook PlatesOHOOKL-8OHOOKL-82016-09-07
00842188101304Hook PlatesOHOOKR-6OHOOKR-62016-09-07
00842188101311Hook PlatesOHOOKR-8OHOOKR-82016-09-07
00842188106514Hex Cortical Screw 3.2mmHEX3.2-08HEX3.2-082016-09-07
00842188106521Hex Cortical Screw 3.2mmHEX3.2-10HEX3.2-102016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095440INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095457INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095464INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095419INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095426INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237736Intraoral Pro Scanning Starter KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26