HTR-PMI

GUDID 00888233028097

BIOMET MICROFIXATION, INC

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable
Primary Device ID00888233028097
NIH Device Record Keyea401b8f-5efa-4b4c-aa77-59cbc61942d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTR-PMI
Version Model NumberPM623241
Company DUNS046189866
Company NameBIOMET MICROFIXATION, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM
Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at Room Temperature. Avoid prolonged exposure to elevated temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]
GS100888233028097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [HTR-PMI]

00841036260682PM620853
00841036258306PM621023
00841036256708PM621082
00841036256463PM620866
00841036255633PM621093
00841036255459PM621166
00841036254988PM621160
00841036253042PM621025
00841036257903PM621187
00841036257781PM621204
00841036256777PM621190
00841036256432PM621213
00841036256227PM621172
00841036256166PM621214-A
00841036256159PM621205-A
00841036256142PM621188
00841036255985PM621208
00841036255831PM621203
00841036255725PM621194
00841036255640PM621186
00841036255626PM621200
00841036255619PM621182
00841036255558PM621202
00841036255541PM621167-A
00841036255466PM621181
00841036255442PM621189
00841036255183PM621170
00841036255176PM621171
00841036255169PM621173
00841036255053PM621169
00841036255046PM621168
00841036260712PM621248
00841036260071PM621265-B
00841036259648PM621226-A
00841036258870PM621226
00841036257699PM621216-A
00841036257682PM621242
00841036257675PM621250
00841036257569PM621227-A
00841036257552PM621260
00841036257521PM621241-A
00841036257446PM621241
00841036257439PM621262
00841036256852PM621243
00841036256371PM621267
00841036256364PM621251
00841036256333PM621252-B
00841036256234PM621232-A
00841036256173PM621249
00841036256135PM621255

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