Inverse/Reverse

GUDID 00889024286009

Inverse/Reverse screw system, 4.5-30

Zimmer GmbH

Total reverse shoulder prosthesis
Primary Device ID00889024286009
NIH Device Record Keya37a618f-9f75-4887-97cc-f934123680b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameInverse/Reverse
Version Model Number01.04223.030
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024286009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2015-10-16

On-Brand Devices [Inverse/Reverse]

00889024286047Inverse/Reverse screw system, 4.5-48
00889024286030Inverse/Reverse screw system, 4.5-42
00889024286023Inverse/Reverse screw system, 4.5-36
00889024286016Inverse/Reverse screw system, 4.5-33
00889024286009Inverse/Reverse screw system, 4.5-30
00889024285996Inverse/Reverse screw system, 4.5-27
00889024285989Inverse/Reverse screw system, 4.5-24
00889024285972Inverse/Reverse screw system, 4.5-18

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