1.5MM SYSTEM SP-2281

GUDID 00888233015851

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00888233015851
NIH Device Record Keybcc68ad6-895b-4a96-b523-48cfd8f76a53
Commercial Distribution StatusIn Commercial Distribution
Brand Name1.5MM SYSTEM
Version Model NumberSP-2281
Catalog NumberSP-2281
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 Datefalse
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888233015851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


[00888233015851]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-02-05
Device Publish Date2020-06-16

On-Brand Devices [1.5MM SYSTEM]

0084103627014872-3100
00841036282776SP-2187
00841036282707SP-2062
00841036282691SP-2061
00841036282684SP-2060
00841036282653SP-2029
0084103613625301-7189
0084103628221901-8613
0084103628220201-8612
0084103628219601-8611
0084103628218901-8610
00841036237097SP-3333
00841036237080SP-3332
00841036237073SP-3331
00841036237066SP-3330
00841036237059SP-3329
00841036237042SP-3328
00841036237035SP-3327
00841036237028SP-3326
00841036237011SP-3325
00841036237004SP-3324
00841036236991SP-3314
00841036236984SP-3313
00841036236977SP-3312
00841036236731SP-3444
00841036236724SP-3445
00841036229993SP-3337
00841036229986SP-3336
00841036226510SP-2082
00841036226503SP-1842
0084103621951291-6103-50
0084103621950591-6104-50
0084103621949991-6105X-50
00841036214104SP-3300
00841036212810SP-3318
00841036202972SP-3258
00841036202965SP-3257
00841036202958SP-3256
00841036197643SP-3224
00841036195786SP-3227
00841036194451SP-3216
00841036191146SP-3217
00841036189952SP-3223
00841036188825SP-3220
00841036188818SP-3002
00841036187934SP-3213
00841036187927SP-3212
00841036185992SP-3214
00841036185466SP-3190
00841036182267SP-3187

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