N/A 00-4928-016-07

GUDID 00889024077478

Zimmer, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00889024077478
NIH Device Record Key56a205ef-a113-4c82-930f-30c6688ac6e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number00-4928-016-07
Catalog Number00-4928-016-07
Company DUNS056038268
Company NameZimmer, Inc.
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 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@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

Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0
Length187 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024077478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


[00889024077478]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-22
Device Publish Date2017-10-02

On-Brand Devices [N/A]

0088902419799200-5852-054-19
0088902419798500-5852-054-18
0088902419797800-5852-054-17
0088902419796100-5852-054-16
0088902419795400-5852-054-15
0088902419794700-5852-054-14
0088902419793000-5852-054-13
0088902419792300-5852-054-12
0088902419791600-5852-052-19
0088902419790900-5852-052-18
0088902419789300-5852-052-17
0088902419788600-5852-052-16
0088902419787900-5852-052-15
0088902419786200-5852-052-14
0088902419785500-5852-052-13
0088902419784800-5852-052-12
0088902419780000-5852-050-19
0088902419779400-5852-050-18
0088902419778700-5852-050-17
0088902419777000-5852-050-16
0088902419776300-5852-050-15
0088902419775600-5852-050-14
0088902419774900-5852-050-13
0088902419773200-5852-050-12
0088902419769500-5852-042-17
0088902419768800-5852-042-09
0088902419630800-5850-070-13
0088902419629200-5850-070-12
0088902419628500-5850-060-26
0088902419627800-5850-060-23
0088902419626100-5850-060-20
0088902419625400-5850-060-17
0088902419624700-5850-060-14
0088902419623000-5850-060-12
0088902419622300-5850-050-26
0088902419621600-5850-050-23
0088902419620900-5850-050-20
0088902419619300-5850-050-17
0088902419618600-5850-050-14
0088902419617900-5850-050-12
0088902419616200-5850-048-20
0088902419615500-5850-048-09
0088902419614800-5850-048-08
0088902419612400-5850-046-45
0088902419611700-5850-046-35
0088902419610000-5850-046-22
0088902419609400-5850-046-20
0088902419608700-5850-046-18
0088902419607000-5850-046-16
0088902419606300-5850-046-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.