FDA.report

SWANSON

Primary DI
00840420189943
Brand
SWANSON
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
4810001
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KWFPROSTHESIS, FINGER, POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KWFProsthesis, Finger, PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840420189943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420189943008404201899438404201899430840420189943

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889797114936SwansonWRIGHT MEDICAL TECHNOLOGY, INC.KWF2026-01-15
00889797114943SwansonWRIGHT MEDICAL TECHNOLOGY, INC.KWF2026-01-15
00840420189950SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420189967SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420189974SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420189981SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420189998SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420190000SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420190017SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420190024SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420190031SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420190048SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420198266SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2016-09-17
00840420121684SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420121691SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127525SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127556SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127563SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127570SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420132789SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420121677SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420121707SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127532SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127549SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420127587SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15
00840420132796SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KWF2015-10-15