FDA.reportPublic FDA data

SWANSON

Primary DI
00840420121899
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
24500000
Catalog number
24500000
Published
2015-10-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWOPROSTHESIS, WRIST, CARPAL SCAPHOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWOProsthesis, Wrist, Carpal ScaphoidOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864490000SWANSON TITANIUM CARPAL SCAPHOID IMPLANTDow Corning Wright1987-04-15KWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420121899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420121899008404201218998404201218990840420121899

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter
Width7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493402642RIVA Posterior Fixation SystemXENIX MEDICAL LLCKWO2025-12-08
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWO2018-03-02
00880304481091MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00880304481107MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00880304481114MAESTRO TOTAL WRISTBiomet Orthopedics, LLCKWO2015-10-24
00840420121905SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-15
00840420129130SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129147SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129154SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129161SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129178SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420129185SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132819SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132826SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132833SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01
00840420132840SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWO2015-10-01