RingLoc Hip System XL-105901

GUDID 00880304461819

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner
Primary Device ID00880304461819
NIH Device Record Key50f3cfda-ef0a-47f2-88dc-d59d87cc989e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRingLoc Hip System
Version Model NumberXL-105901
Catalog NumberXL-105901
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304461819 [Primary]
GS100880304461819 [Primary]
GS100880304461819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [RingLoc Hip System]

00880304926943EP-105905
00880304658950CP560485
00880304652064XL-196238
00880304652057XL-196237
00880304652040XL-196236
00880304652033XL-196235
00880304652026XL-195238
00880304652019XL-195237
00880304652002XL-195236
00880304651999XL-195235
00880304651982XL-195234
00880304651975XL-185238
00880304651968XL-185237
00880304651951XL-185236
00880304651944XL-185235
00880304651937XL-185234
00880304651920XL-185233
00880304651913XL-176238
00880304651906XL-176237
00880304651890XL-176236
00880304651883XL-176235
00880304651876XL-175232
00880304651869XL-166238
00880304651852XL-166237
00880304651845XL-166236
00880304651838XL-166235
00880304651821XL-166234
00880304651654XL-109928
00880304651647XL-109927
00880304651630XL-109926
00880304651623XL-108528
00880304651616XL-108527
00880304651609XL-108526
00880304651593XL-108525
00880304651586XL-108524
00880304651579XL-108428
00880304651562XL-108427
00880304651555XL-108426
00880304651548XL-108425
00880304651531XL-108424
00880304651524XL-108323
00880304651517XL-108322
00880304651500XL-108321
00880304651494XL-108223
00880304651487XL-108222
00880304651470XL-108221
00880304651463XL-107928
00880304651456XL-107927
00880304651449XL-107926
00880304651432XL-107828

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