FDA.reportPublic FDA data

REMOTION

Primary DI
00886385015071
Brand
REMOTION
Company
Stryker GmbH
Model
300-4800
Catalog number
300-4800
Device description
Wrist Instr.Carpal Ball Trial, Plus, S
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
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
00886385015071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385015071008863850150718863850150710886385015071

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
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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