SMPLE SUBMUSCULAR PLATING SYSTEM 14-448445

GUDID 00888480445821

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00888480445821
NIH Device Record Keyc349dae2-32a6-4597-b75b-750f56433443
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMPLE SUBMUSCULAR PLATING SYSTEM
Version Model Number14-448445
Catalog Number14-448445
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888480445821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

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 [SMPLE SUBMUSCULAR PLATING SYSTEM]

0088030459231514-448805S
0088030459228514-448800S
0088030459227814-448800
0088786815144614-448674
0088786815143914-448439
0088786815142214-448434
0088786815141514-448425
0088786815140814-448411
0088786810687314-448675
0088786809955714-448671
0088786809954014-448666
0088786809953314-448661
0088786809952614-448656
0088786809951914-448651
0088786809944114-448466
0088786809943414-448461
0088786809942714-448456
0088786809941014-448451
0088786809940314-448446
0088786809939714-448441
0088786809938014-448437
0088786809937314-448433
0088786809936614-448431
0088786809935914-448429
0088786809934214-448427
0088786809933514-448426
0088786809932814-448423
0088786809931114-448421
0088786809930414-448419
0088786809929814-448417
0088786809928114-448415
0088786809921214-448337
0088786809920514-448333
0088786809919914-448331
0088786809918214-448329
0088786809917514-448327
0088786809916814-448325
0088786809915114-448323
0088786809914414-448321
0088786809913714-448319
0088786809912014-448317
0088786809911314-448315
0088786809909014-448218
0088786809908314-448216
0088786809907614-448214
0088786809906914-448212
0088786809905214-448210
0088786809903814-448118
0088786809902114-448116
0088786809901414-448114

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