FDA.reportPublic FDA data

ACUMED

Primary DI
10806378069437
Brand
ACUMED
Company
Acumed LLC
Model
HR-0054-S
Device description
4mm Polarus® Cap Screw Assembly
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBSINSTRUMENT, CLIP FORMING/CUTTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBSInstrument, Clip Forming/CuttingNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378069437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637806943710806378069437

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)627-9957businessservices@acumed.net

Regulatory Flags#

DUNS number
196884852
Device count
1
Lot or batch
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
00849233010437BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010444BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
00849233010635Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
30849233010438BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010441BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HBS2023-12-15
10849233010632Busse Hospital DisposablesROBERT BUSSE & CO., INC.HBS2023-12-15
07899893233069NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-31
07899893262038NEONAILNeoortho Produtos Ortopédicos S/A.HBS2023-10-27
08903993392645EXPERT TIBIA NAILAuxein Medical Private LimitedHBS2020-10-21
07540194008572SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008589SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008596SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008602SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008619SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008626SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008633SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008640SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008657SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008664SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008671SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008688SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008695SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008701SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008718SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008725SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008732SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008749SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008756SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008763SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12
07540194008770SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMOrthopediatrics Canada ULCHBS2019-07-12