FDA.reportPublic FDA data

ACUMED

Primary DI
10806378115486
Brand
ACUMED
Company
Acumed LLC
Model
80-4011
Device description
Clavicle Hook Plate Depth Sizer, Left
Published
2023-01-08
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378115486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637811548610806378115486

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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00840286860178Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860192Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860208Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860239Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860253Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860260Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860314Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860321Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860338Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860369Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860376Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
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00840286860437Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860451Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860475Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860499Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860512Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10
00840286860536Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-10