FDA.reportPublic FDA data

REMOTION

Primary DI
00886385014784
Brand
REMOTION
Company
Stryker GmbH
Model
300-2500
Catalog number
300-2500
Device description
Wrist Instr. Radial Broach Right, 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
HTQBROACH
JWJPROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385014784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385014784008863850147848863850147840886385014784

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
Premarket 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
10603295079965AML EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080176EXCEL TRI-LOCKDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080183EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080190EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080206EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080213EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080220EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080237EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080244EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080251NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080268NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10381780280019KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HTQ2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HTQ2018-04-13
10381780279679Katalyst™ Bipolar Radial Head SystemAscension Orthopedics, Inc.HTQ2018-04-10
10381780279686Katalyst™ Bipolar Radial Head SystemAscension Orthopedics, Inc.HTQ2018-04-10
10381780279877KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HTQ2018-04-10
10381780279884KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HTQ2018-04-10
10381780278535Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278566Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278573Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278580Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278597Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278603Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278610Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278627Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278634Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278955Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278962Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278979Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.HTQ2018-03-09
10381780278986Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.HTQ2018-03-09