TT MB Peg 1375.14.664

GUDID 08033390087902

SMR TT Metal Back Peg (Ti6Al4V) - S/STD X-Long

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID08033390087902
NIH Device Record Key8019d144-40b5-4145-b594-b4375de7b1db
Commercial Distribution StatusIn Commercial Distribution
Brand NameTT MB Peg
Version Model NumberTT Glenoid
Catalog Number1375.14.664
Company DUNS432066322
Company NameLIMACORPORATE SPA
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390087902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2015-08-04

On-Brand Devices [TT MB Peg ]

08033390087902SMR TT Metal Back Peg (Ti6Al4V) - S/STD X-Long
08033390087896SMR TT Metal Back Peg (Ti6Al4V) - S-R X-Long
08033390084437SMR TT Metal Back Peg (Ti6Al4V) - S/STD Long
08033390084420SMR TT Metal Back Peg (Ti6Al4V) - S/STD Medium
08033390084413SMR TT Metal Back Peg (Ti6Al4V) - S/STD Short
08033390084383SMR TT Metal Back Peg (Ti6Al4V) - S-R Short

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