DELTA Multihole TT Pro 5554.14.706

GUDID 08033390151467

Acetabular Cup Dia. 70 mm (Liner # 2 EXTRA-LARGE)

LIMACORPORATE SPA

Metallic acetabulum prosthesis
Primary Device ID08033390151467
NIH Device Record Key8866a01a-57d6-4544-bcf0-1099fa4d122f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDELTA Multihole TT Pro
Version Model Number5554.14.706
Catalog Number5554.14.706
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
GS108033390151467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-18
Device Publish Date2019-11-09

On-Brand Devices [DELTA Multihole TT Pro]

08033390151498Acetabular Cup Dia. 76 mm (Liner # 2 EXTRA-LARGE)
08033390151481Acetabular Cup Dia. 74 mm (Liner # 2 EXTRA-LARGE)
08033390151474Acetabular Cup Dia. 72 mm (Liner # 2 EXTRA-LARGE)
08033390151467Acetabular Cup Dia. 70 mm (Liner # 2 EXTRA-LARGE)
08033390151450Acetabular Cup Dia. 68 mm (Liner # 2 EXTRA-LARGE)
08033390151443Acetabular Cup Dia. 66 mm (Liner #EXTRA-LARGE)
08033390151436Acetabular Cup Dia. 64 mm (Liner #EXTRA-LARGE)
08033390151429Acetabular Cup Dia. 62 mm (Liner #EXTRA-LARGE)
08033390151412Acetabular Cup Dia. 60 mm (Liner #EXTRA-LARGE)
08033390151405Acetabular Cup Dia. 58 mm (Liner #LARGE+)
08033390151399Acetabular Cup Dia. 56 mm (Liner #LARGE+)
08033390151382Acetabular Cup Dia. 54 mm (Liner #MEDIUM+)
08033390151207Acetabular Cup Dia. 52 mm (Liner #MEDIUM+)
08033390151191Acetabular Cup Dia. 50 mm (Liner #MEDIUM+)
08033390151184Acetabular Cup Dia. 48 mm (Liner #MEDIUM-)
08033390151115Acetabular Cup Dia. 46 mm (Liner #MEDIUM-)
08033390151108Acetabular Cup Dia. 44 mm (Liners #SMALL)

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