BioBall DELTA™ Ceramic Head HM50036

GUDID 04048266025470

ISO 6474-2 sterile

Merete GmbH

Ceramic femoral head prosthesis
Primary Device ID04048266025470
NIH Device Record Keycc1a808f-9f7a-4ff6-8c73-287b820f6d91
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioBall DELTA™ Ceramic Head
Version Model Number36
Catalog NumberHM50036
Company DUNS313267265
Company NameMerete 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

Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone630-613-7182
Emailservice@merete.medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com
Phone+1(630)869-1092
Emailservice@merete-medical.com

Device Dimensions

Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104048266025470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-09-09
Device Publish Date2015-10-15

On-Brand Devices [BioBall DELTA™ Ceramic Head]

04048266025470ISO 6474-2 sterile
04048266025463ISO 6474-2 sterile
04048266025456ISO 6474-2 sterile

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