FDA.reportPublic FDA data

TREGOR®

Primary DI
03663703000240
Brand
TREGOR®
Company
ASTON MEDICAL
Model
37051
Catalog number
12628970U
Device description
Uncemented + cup
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
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663703000240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663703000240036637030002403663703000240

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes#

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

Sterilization Methods#

Method table
Method

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24