FDA.reportPublic FDA data

ACUMED

Primary DI
10806378115387
Brand
ACUMED
Company
Acumed LLC
Model
80-3927
Device description
2.7mm Low Profile Screw Caddy Lid
Published
2024-07-05
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
K233311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233311000Acumed Wrist Plating SystemAcumed, LLC2024-04-22HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378115387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637811538710806378115387

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(888)627-9957businessservices@acumed.net

Regulatory Flags#

DUNS number
196884852
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10806378067341ACUMEDFX-4000-S2015-10-24
10806378067372ACUMEDFX-4001-S2015-10-24
10806378067426ACUMEDFX-4004-S2015-10-24
10806378067594ACUMEDFX-4054-S2015-10-24
10806378040368ACUMED80-01802015-10-24
10806378099182ACUMED4014-0600-S2023-01-08
10806378116094ACUMED80-39662023-01-08
10806378116131ACUMED4014-0705-S2023-01-08
10806378116148ACUMED4014-0710-S2023-01-08
10806378116155ACUMED4014-0715-S2023-01-08
10806378099175ACUMED4014-06002024-12-18
10806378116971ACUMED4014-07052024-12-18
10806378116988ACUMED4014-07102024-12-18
10806378116995ACUMED4014-07152024-12-18
10806378105296ACUMED80-34522020-03-22
10806378111976ACUMED80-36582019-08-12
10806378124273ACUMED80-42452025-12-08
10806378124280ACUMED80-43232025-12-08
10806378124297ACUMED80-43222025-12-08
10806378124310ACUMED7006-3401N2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23
00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
18059015378368Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378375Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378382Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
00841731153258ARTEMIS FUZEVILEX LLCFSM2026-07-22
00841731153265ARTEMIS TAKEDOWNVILEX LLCFSM2026-07-22
B803PW12A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW14G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW18A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW20ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW22A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW26A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW30A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW32A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW40A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
00843059127478LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FSM2026-07-20
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17