FDA.reportPublic FDA data

UNI-ELBOW

Primary DI
00886385025964
Brand
UNI-ELBOW
Company
Stryker GmbH
Model
410-0003
Catalog number
410-0003
Device description
Radio Capitellum Small, Right
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385025964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385025964008863850259648863850259640886385025964

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886385017365STAR908-0110-02908-0110-022022-02-14
00886385018836STAR933-0003-02933-0003-022022-02-14
00886385018843STAR933-0003-03933-0003-032022-02-14
00886385019055STAR933-0025-02933-0025-022022-02-14
00886385019062STAR933-0025-03933-0025-032022-02-14
00886385019147STAR933-0029-02933-0029-022022-02-14
00886385017150STAR905-0066905-00662020-09-24
07613327350296NA2351-00202351-00202018-11-02
07613327361650NA2351-01402351-01402018-11-02
07613327361667NA2351-03402351-03402018-11-02
07613327361674NA2351-00302351-00302018-11-02
07613327361681NA2351-00602351-00602018-11-02
07613327361780NA2351-42902351-42902018-11-02
07613327368154NA2351-00702351-00702018-11-02
07613327368178NA2351-42802351-42802018-11-02
07613327376197NA2351-04202351-04202018-11-01
07613327376203NA2351-03802351-03802018-11-01
00886385016412STAR™400-2502017-06-27
00886385016429STAR™400-2512017-06-27
00886385016436STAR™400-2522017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846832012466Latitude™ - ElbowTORNIER, INC.JDB2022-03-31
93700386926603TEST-SALTO TALARISTORNIERJDB2019-12-23
08033390126465TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390126922TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128810TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128827TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128834TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128858TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128889TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138093TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138116TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138130TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138185TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138215TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138239TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138253TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138284TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138307TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138321TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138383TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138437TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138444TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138451TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138468TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138499TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138505TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138529TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138536TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138543TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138550TEMA ElbowLIMACORPORATE SPAJDB2019-05-24