TM Handle SSI005889

GUDID 00889024588967

Zimmer, Inc.

Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable Bone-coring punch, reusable
Primary Device ID00889024588967
NIH Device Record Keye2386954-3255-4f66-90bb-9f8d5c9e963d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM Handle
Version Model NumberSSI005889
Catalog NumberSSI005889
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com
Phone1 (800) 343-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]
GS100889024588967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


[00889024588967]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by Zimmer, Inc.

00889024187771 - NA2020-07-01
00889024218178 - NexGen®2020-06-23
00889024218574 - NA2020-06-23
00889024219090 - NexGen®2020-06-23
00889024219281 - NexGen®2020-06-23
00889024219311 - NexGen®2020-06-23
00889024219373 - NexGen®2020-06-23
00889024219458 - NexGen® Legacy®2020-06-23

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