RECAP HIP SYSTEM US157138

GUDID 00880304473515

Biomet Orthopedics, LLC

Metallic femoral head prosthesis
Primary Device ID00880304473515
NIH Device Record Key5861c302-16de-4752-abf4-4c167fd7ff8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRECAP HIP SYSTEM
Version Model NumberUS157138
Catalog NumberUS157138
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304473515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXAProsthesis, hip, femoral, resurfacing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [RECAP HIP SYSTEM]

00880304684645US157360
00880304684621US157358
00880304684607US157356
00880304684584US157354
00880304684560US157352
00880304684546US157350
00880304684522US157348
00880304684508US157346
00880304684485US157344
00880304684461US157342
00880304684447US157340
00880304684423US157338
00880304684416US157260
00880304684409US157259
00880304684393US157258
00880304684386US157257
00880304684379US157256
00880304684362US157255
00880304684355US157254
00880304684348US157253
00880304684331US157252
00880304684324US157251
00880304684317US157250
00880304684300US157249
00880304684294US157247
00880304684287US157246
00880304684270US157245
00880304684263US157244
00880304684256US157243
00880304684249US157242
00880304684232US157241
00880304684225US157240
00880304684218US157239
00880304684201US157238
00880304473584US157156
00880304473522US157146
00880304473515US157138
00880304473508US157142
00880304473492US157144
00880304473485US157140
00880304473478US157150
00880304473461US157158
00880304473454US157160
00880304473447US157154
00880304473430US157152
00880304462465US157248
00880304462458US157148
00880304247871157257
00880304247864157255
00880304247857157253

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