COMPRESS DEVICE 178565

GUDID 00880304528697

Biomet Orthopedics, LLC

Knee stem
Primary Device ID00880304528697
NIH Device Record Key5e37fc74-cf2d-413e-b62a-188bec72b861
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPRESS DEVICE
Version Model Number178565
Catalog Number178565
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304528697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-22
Device Publish Date2015-10-24

On-Brand Devices [COMPRESS DEVICE]

00880304554979178951
00880304554962178950
00880304554955178803
00880304554948178799
00880304554931178789
00880304554924178788
00880304554917178787
00880304554900178786
00880304554894178785
00880304554887178784
00880304554870178759
00880304554863178758
00880304554856178756
00880304554849178755
00880304554832178754
00880304554825178569
00880304528697178565
00880304528352178559
00880304525740178561
00880304525733178563
00880304523951178567
00880304509672178757
00880304509139178370
00880304509122178373
00880304509115178364
00880304509108178368
00880304509092178356
00880304509085178360
00880304509078178354
00880304509061178355
00880304509054178353
00880304509047178366
00880304509030178365
00880304509023178350
00880304509016178361
00880304509009178369
00880304508996178371
00880304508989178359
00880304508972178358
00880304508965178362
00880304508958178357
00880304508941178351
00880304508934178352
00880304508927178363
00880304508910178367
00880304508903178372
00880304505094178729
00880304502062178727
00880304500525178726
00880304500518178724

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.