Precision Mixing & Delivery System

GUDID 00889024205574

Zimmer, Inc.

Bone graft delivery kit
Primary Device ID00889024205574
NIH Device Record Key6e345b77-0cec-4105-b8fb-ae8ce2913fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Mixing & Delivery System
Version Model Number76-6048
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25 Degrees Celcius

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024205574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [Precision Mixing & Delivery System]

0088902420560476-6049
0088902420559876-6050
0088902420558176-6047
0088902420557476-6048

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