FDA.reportPublic FDA data

HCS-SCREWLID1.7

Primary DI
00842188129797
Brand
HCS-SCREWLID1.7
Company
Trimed, INC.
Model
HCS-SCREWLID1.7
Catalog number
HCS-SCREWLID1.7
Device description
1.7 Caddy Lid
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243943000TriMed® Compression ScrewsTriMed, Inc.2025-04-10HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188129797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188129797008421881297978421881297970842188129797

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
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00190446960386Active AdaptiveMedshape, Inc.FSM2026-10-09
00850045406615clamp-itGeneral Hospital Supply CorpFSM2026-10-01
00190776434588MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776434595MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776435899MillenniumAvalign Technologies, Inc.FSM2026-09-30
16931918122397AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918176680AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918191614AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
10888857253056DENALI® Spinal SystemVB Spine LLCFSM2025-12-18
10888857291980MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857446267MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857381551YUKON OCT Spinal SystemVB Spine LLCFSM2025-12-09
10888857291850MESA® Spinal SystemVB Spine LLCFSM2025-12-08
10888857446274MESA® Spinal SystemVB Spine LLCFSM2025-12-08
10888857423190Brainlab Compatible K2M Navigation InstrumentsVB Spine LLCFSM2025-09-09
10888857423206Brainlab Compatible K2M Navigation InstrumentsVB Spine LLCFSM2025-09-09
10888857431485CAYMAN® Plate SystemVB Spine LLCFSM2025-09-09
10888857433922Brainlab Compatible K2M Navigation InstrumentsVB Spine LLCFSM2025-09-09
10888857454569CAYMAN® Plate SystemVB Spine LLCFSM2025-09-09