N/A

GUDID 00889024302815

Awl Cone Prosthesis ø 17

Zimmer GmbH

Joint prosthesis implantation kit, reusable
Primary Device ID00889024302815
NIH Device Record Key57dbafe9-851e-4dc4-9cbe-ec4c2a738728
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number75.11.15-170
Company DUNS488133448
Company NameZimmer GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com
Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Outer Diameter17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024302815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


[00889024302815]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2016-11-07

On-Brand Devices [N/A]

00889024283305DURASUL CoCr Head 38/+8 'XL' 12/14
00889024283299DURASUL CoCr Head 38/+4 'L' 12/14
00889024283282DURASUL CoCr Head 38/ 0 'M' 12/14
00889024283275DURASUL CoCr Head 38/-4 S 12/14
00889024283268DURASUL CoCr Head 38/-8 'XS' 12/14
00889024302907Gauge for the medullary cavity
00889024302884Awl Cone Prosthesis ø 24
00889024302877Awl Cone Prosthesis ø 23
00889024302860Awl Cone Prosthesis ø 22
00889024302853Awl Cone Prosthesis ø 21
00889024302846Awl Cone Prosthesis ø 20
00889024302839Awl Cone Prosthesis ø 19
00889024302822Awl Cone Prosthesis ø 18
00889024302815Awl Cone Prosthesis ø 17
00889024302808Awl Cone Prosthesis ø 16
00889024302792Awl Cone Prosthesis ø 15
00889024302785Awl Cone Prosthesis ø 14
00889024302778Awl Cone Prosthesis ø 13
00889024302761Impactor Cone Prosthesis
00889024298347Kirschner wire, with trocar tip, ø 2.0 m
00889024298330Kirschner wire, with trocar tip, ø 2.0 m
00889024298323Kirschner wire
00889024295629Locking screw, self-tapping, ø 4.9 mm, 100 mm
00889024295605Locking screw, self-tapping, ø 4.9 mm, 90 mm
00889024295575Locking screw, self-tapping, ø 4.9 mm, 76 mm
00889024295568Locking screw, self-tapping, ø 4.9 mm, 72 mm
00889024295551Locking screw, self-tapping, ø 4.9 mm, 68 mm
00889024295513Locking screw, self-tapping, ø 4.9 mm, 56 mm
00889024295490Locking screw, self-tapping, ø 4.9 mm, 52 mm
00889024295483Locking screw, self-tapping, ø 4.9 mm, 48 mm
00889024295476Locking screw, self-tapping, ø 4.9 mm, 46 mm
00889024295452Locking screw, self-tapping, ø 4.9 mm, 42 mm
00889024295438Locking screw, self-tapping, ø 4.9 mm, 38 mm
00889024295421Locking screw, self-tapping, ø 4.9 mm, 36 mm
00889024295407Locking screw, self-tapping, ø 4.9 mm, 32 mm
00889024295391Locking screw, self-tapping, ø 4.9 mm, 30 mm
00889024295384Locking screw, self-tapping, ø 4.9 mm, 28 mm
00889024295377Locking screw, self-tapping, ø 4.9 mm, 26 mm
00889024295360Locking screw, self-tapping, ø 4.9 mm, 24 mm
00889024295353Cortical screw ø 3.5 self-tapping L.85
00889024295346Cortical screw ø 3.5 self-tapping L.80
00889024295339Cortical screw ø 3.5 self-tapping L.75
00889024295322Cortical screw ø 3.5 self-tapping L.70
00889024295315Cortical screw ø 3.5 self-tapping L.65
00889024295308Cortical screw ø 3.5 self-tapping L.60
00889024295292Cortical screw ø 3.5 self-tapping L.55
00889024295285Cortical screw ø 3.5 self-tapping L.50
00889024295278Cortical screw ø 3.5 self-tapping L.45
00889024295261Cortical screw ø 3.5 self-tapping L.40
00889024295254Cortical screw ø 3.5 self-tapping L.38

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