FDA.reportPublic FDA data

REMOTION

Primary DI
00886385014814
Brand
REMOTION
Company
Stryker GmbH
Model
300-2800
Catalog number
300-2800
Device description
Wrist Instr. PGT Carpal Template, L
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
00886385014814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385014814008863850148148863850148140886385014814

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. 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
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
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

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