FDA.reportPublic FDA data

Duocentric®

Primary DI
03663703000653
Brand
Duocentric®
Company
ASTON MEDICAL
Model
50038-US
Catalog number
30112584
Device description
Reversed cemented humeral stem
Published
2015-09-16
Public version status
Update
Distribution status
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663703000653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663703000653036637030006533663703000653

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+33477930004info@aston-medical.com

Regulatory Flags#

DUNS number
576503098
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663703001087Duocentric®600020305019412015-09-16
03663703000981Duocentric®50438STER835020412015-09-16
03663703000998Duocentric®50439STER835025412015-09-16
03663703001001Duocentric®50440STER835030412015-09-16
03663703001018Duocentric®50441STER835035412015-09-16
03663703001025Duocentric®50442STER835040412015-09-16
03663703001032Duocentric®50443STER835045412015-09-16
03663703001049Duocentric®43014STER760420412015-09-16
03663703001056Duocentric®43015STER760425412015-09-16
03663703001063Duocentric®43016STER760430412015-09-16
03663703001070Duocentric®43017STER760435412015-09-16
03663703000073TREGOR®20009312521970U2015-09-16
03663703000080TREGOR®20009412541970U2015-09-16
03663703000097TREGOR®20009512561970U2015-09-16
03663703000103TREGOR®20009612581970U2015-09-16
03663703000110TREGOR®20009712601970U2015-09-16
03663703000127TREGOR®20009812621970U2015-09-16
03663703000134TREGOR®3703912521978U2015-09-16
03663703000141TREGOR®3704012541978U2015-09-16
03663703000158TREGOR®3704112561978U2015-09-16

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Primary DI, Brand, Company table
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00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
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10885862657329EquinoxeExactech, Inc.KWS2026-07-07
10885862657336EquinoxeExactech, Inc.KWS2026-07-07
10885862657343EquinoxeExactech, Inc.KWS2026-07-07
10885862657350EquinoxeExactech, Inc.KWS2026-07-07
10885862657367EquinoxeExactech, Inc.KWS2026-07-07
10885862657374EquinoxeExactech, Inc.KWS2026-07-07
10885862657381EquinoxeExactech, Inc.KWS2026-07-07
10885862657398EquinoxeExactech, Inc.KWS2026-07-07
10885862657442EquinoxeExactech, Inc.KWS2026-07-07