FDA.reportPublic FDA data

NA

Primary DI
00889797998161
Brand
NA
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
5881003540
Catalog number
5881003540
Published
2016-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797998161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797998161008897979981618897979981610889797998161

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
08809986485137CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485144CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485151CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485168CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485274CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485281CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485298CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485304CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485311CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485328CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485335CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485342CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485359CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485366CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485373CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485380CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485397CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485403CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485410CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485427CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485434CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485441CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485458CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485465CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485472CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485588CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29