FDA.reportPublic FDA data

RHEAD

Primary DI
00886385023762
Brand
RHEAD
Company
Stryker GmbH
Model
17-0972
Catalog number
17-0972
Device description
Standard Stem Trial; 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
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385023762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385023762008863850237628863850237620886385023762

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
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
10886982300713NASynthes GmbHKWI2020-06-17
10886982300720NASynthes GmbHKWI2020-06-17
10886982300522NASynthes GmbHKWI2020-06-08
10886982300539NASynthes GmbHKWI2020-06-08
10886982300546NASynthes GmbHKWI2020-06-08
10886982300553NASynthes GmbHKWI2020-06-08
10886982300560NASynthes GmbHKWI2020-06-08
10886982300577NASynthes GmbHKWI2020-06-08
10886982300584NASynthes GmbHKWI2020-06-08
10886982300591NASynthes GmbHKWI2020-06-08
10886982300607NASynthes GmbHKWI2020-06-08
10886982300614NASynthes GmbHKWI2020-06-08
10886982300621NASynthes GmbHKWI2020-06-08
10886982300638NASynthes GmbHKWI2020-06-08
10886982300645NASynthes GmbHKWI2020-06-08
10886982300652NASynthes GmbHKWI2020-06-08
10886982300669NASynthes GmbHKWI2020-06-08
10886982300676NASynthes GmbHKWI2020-06-08
10886982300683NASynthes GmbHKWI2020-06-08
10886982300690NASynthes GmbHKWI2020-06-08
10886982300706NASynthes GmbHKWI2020-06-08
10886982300737NASynthes GmbHKWI2020-06-08
10886982300744NASynthes GmbHKWI2020-06-08
10886982300751NASynthes GmbHKWI2020-06-08
10886982300768NASynthes GmbHKWI2020-06-08
10886982300775NASynthes GmbHKWI2020-06-08
10886982300782NASynthes GmbHKWI2020-06-08
10886982300799NASynthes GmbHKWI2020-06-08
10886982300805NASynthes GmbHKWI2020-06-08
10886982300812NASynthes GmbHKWI2020-06-08