FDA.reportPublic FDA data

Duocentric®

Primary DI
03663703000899
Brand
Duocentric®
Company
ASTON MEDICAL
Model
50227
Catalog number
30440040
Device description
Retentive humeral insert
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
03663703000899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663703000899036637030008993663703000899

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

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
Primary DIBrandCompanyProduct codePublished
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
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00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
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
10885862657244EquinoxeExactech, Inc.KWS2026-07-07
10885862657251EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.KWS2026-07-07
10885862657275EquinoxeExactech, Inc.KWS2026-07-07
10885862657282EquinoxeExactech, Inc.KWS2026-07-07
10885862657299EquinoxeExactech, Inc.KWS2026-07-07
10885862657305EquinoxeExactech, Inc.KWS2026-07-07
10885862657312EquinoxeExactech, Inc.KWS2026-07-07
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
10885862657459EquinoxeExactech, Inc.KWS2026-07-07