FDA.reportPublic FDA data

SWANSON II

Primary DI
00840420130624
Brand
SWANSON II
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
G4880302J
Published
2016-09-17
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
KIGPROSTHESIS, WRIST, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIGProsthesis, Wrist, Constrained, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420130624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420130624008404201306248404201306240840420130624

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
807201207
Device count
1
Premarket exempt
true
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
00889797069298INVISION™60006027600060272022-11-16
00889797103619PROSTEP™ MICA™57790001577900012022-02-01
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840420130617SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130631SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130648SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420130655SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420198860SWANSON IIWRIGHT MEDICAL TECHNOLOGY, INC.KIG2016-09-17
00840420129048SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129055SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129062SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129079SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15
00840420129086SWANSONWRIGHT MEDICAL TECHNOLOGY, INC.KIG2015-10-15