FDA.reportPublic FDA data

REMOTION

Primary DI
00886385015521
Brand
REMOTION
Company
Stryker GmbH
Model
WA/R-LL
Catalog number
WA/R-LL
Device description
Wrist Left Radial Implant, Large
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
JWJPROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385015521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385015521008863850155218863850155210886385015521

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist prosthesisA sterile implantable artificial substitute for a wrist joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes radial and carpal components, usually with an intervening ball/spacer, with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without 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
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
00885556854839Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854846Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854853Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855249Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855256Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855263Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855270Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855287Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855294Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855553Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855560Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855577Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855584Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855591Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855607Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855614Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855621Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855638Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855669Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855676Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855683Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855690Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855706Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855713Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855720Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855737Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855744Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855751Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855768Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855775Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22