FDA.reportPublic FDA data

RHEAD

Primary DI
00886385023267
Brand
RHEAD
Company
Stryker GmbH
Model
314-0101
Catalog number
314-0101
Device description
Extended Stem Broach; Size 1
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00886385023267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385023267008863850232678863850232670886385023267

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327172645ASNIS7053557053552016-07-25
07613327172652ASNIS705355S705355S2016-07-25
07613327172690ASNIS7053607053602016-07-25
07613327172706ASNIS7053637053632016-07-25
07613327172720ASNIS7053627053622016-07-25
07613327172737ASNIS7053657053652016-07-25
07613327172751ASNIS7053647053642016-07-25
07613327172768ASNIS7053617053612016-07-25
07613327172775ASNIS7053697053692016-07-25
07613327172812ASNIS7053717053712016-07-25
07613327172843ASNIS7053707053702016-07-25
07613327172867ASNIS7053667053662016-07-25
04546540112859NA7026227026222020-09-24
04546540112927NA7026297026292020-09-24
04546540145321BIXCUT0225-60750225-60752020-04-07
04546540145338BIXCUT0225-60800225-60802020-04-07
04546540145369BIXCUT0225-60950225-60952020-04-07
04546540145376BIXCUT0225-61000225-61002020-04-07
04546540145390BIXCUT0225-61100225-61102020-04-07
04546540145413BIXCUT0225-81150225-81152020-04-07

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