SMR TT Augmented 360 1375.15.565

GUDID 08033390180337

SMR TT Augmented 360 Baseplate S-R 15°X

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID08033390180337
NIH Device Record Keybc6a2fb0-2874-44d8-acec-f281481f538f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR TT Augmented 360
Version Model Number1375.15.565
Catalog Number1375.15.565
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 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
GS108033390180337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-07
Device Publish Date2020-11-27

On-Brand Devices [SMR TT Augmented 360]

08033390162104SMR TT Augmented 360 Baseplate S-R +4mm, Dia. 27 mm
08033390161848SMR TT Augmented 360 Baseplate S-R +2mm, Dia. 27 mm
08033390161473SMR TT Augmented 360 Baseplate S-R 15°, Dia. 27 mm
08033390161466SMR TT Augmented 360 Baseplate S-R 10°, Dia. 27 mm
08033390161459SMR TT Augmented 360 Baseplate S-R 7°, Dia. 27 mm
08033390180337SMR TT Augmented 360 Baseplate S-R 15°X
08033390180320SMR TT Augmented 360 Baseplate S-R 10°X
08033390180313SMR TT Augmented 360 Baseplate S-R 7°X
08033390180047SMR TT Augmented 360 Baseplate S-R 19°X
08033390161503SMR TT Augmented 360 Baseplate S-R 19°

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