NovoHip Total Hip System 1400-2000

GUDID 00811382033490

Taper Rasp, GBC Sz 20.0

NOVOSOURCE, LLC

Joint prosthesis implantation kit, reusable
Primary Device ID00811382033490
NIH Device Record Key195c598a-6dfb-4456-9b86-6650d1f2d241
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoHip Total Hip System
Version Model Number1400-2000
Catalog Number1400-2000
Company DUNS081034828
Company NameNOVOSOURCE, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx
Phone3045542167
Emailxx@xx.xx

Device Dimensions

Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100811382033490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

[00811382033490]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-12
Device Publish Date2018-02-27

On-Brand Devices [NovoHip Total Hip System]

00811382037122Liner, Elevated Face Sz 58x36
00811382037115Liner, Neutral Face Sz 58x36
00811382037108Taper Stem, Ext Offset Sz 16.25
00811382037092Taper Stem, Std Offset Sz 16.25
00811382037085NH Bi-Polar Trial Case
00811382037078NH Hemis Reamer Case
00811382037061NH Acetabular Prep Case
00811382037054NH Femoral Prep Case
00811382034664Handle, Straight Reamer
00811382034602Flex Depth Gage
00811382034565Handle, Head Impactor
00811382034503Hemispherical Reamer Sz 63
00811382034428Hemispherical Reamer Sz 53
00811382034367Hemispherical Reamer Sz 47
00811382034336Head Impactor Sz 40
00811382034299Adapter, Trial 16/18 - 12/14 XL
00811382034282Adapter, Trial 16/18 - 12/14 L
00811382034275Adapter, Trial 16/18 - 12/14 M
00811382034268Adapter, Trial 16/18 - 12/14 S
00811382034251Trial Neck, Ext Sz 7.5 - 22.5
00811382034244Trial Liner, Elevated Face Sz 66x40
00811382034237Trial Liner, Elevated Face Sz 66x32
00811382034220Trial Liner, Elevated Face Sz 66x28
00811382034213Trial Liner, Elevated Face Sz 62x40
00811382034206Trial Liner, Elevated Face Sz 62x32
00811382034190Trial Liner, Elevated Face Sz 62x28
00811382034183Trial Liner, Elevated Face Sz 58x40
00811382034176Trial Liner, Elevated Face Sz 58x32
00811382034169Trial Liner, Elevated Face Sz 58x28
00811382034152Trial Liner, Elevated Face Sz 54x36
00811382034145Trial Liner, Elevated Face Sz 54x32
00811382034138Trial Liner, Elevated Face Sz 54x28
00811382034121Trial Liner, Elevated Face Sz 52x36
00811382034114Trial Liner, Elevated Face Sz 52x32
00811382034107Trial Liner, Elevated Face Sz 52x28
00811382034091Trial Liner, Elevated Face Sz 50x32
00811382034084Trial Liner, Elevated Face Sz 50x28
00811382034077Trial Liner, Elevated Face Sz 46x28
00811382034060Femoral Option Head, Trial Sz 40
00811382034053Femoral Option Head, Trial Sz 36
00811382034046Femoral Option Head, Trial Sz 32
00811382034039Femoral Option Head, Trial Sz 28
00811382034022Trial Liner, Elevated Face Sz 66x40
00811382034015Trial Liner, Elevated Face Sz 66x32
00811382034008Trial Liner, Elevated Face Sz 66x28
00811382033995Trial Liner, Elevated Face Sz 62x40
00811382033988Trial Liner, Elevated Face Sz 62x32
00811382033971Trial Liner, Elevated Face Sz 62x28
00811382033964Trial Liner, Elevated Face Sz 58x40
00811382033957Trial Liner, Elevated Face Sz 58x32
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