NovoHip Total Hip System 1713-154-301

GUDID 00811382038952

Femoral Prep Upper Tray - Classic Rasp

NOVOSOURCE, LLC

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00811382038952
• NIH Device Record Key: 5620f6d4-1027-4dd8-a2d4-352e773ccd93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoHip Total Hip System
• Version Model Number: 1713-154-301
• Catalog Number: 1713-154-301
• Company DUNS: 081034828
• Company Name: NOVOSOURCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com
• Phone: 3045542167
• Email: info@novosource.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811382038952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140701

FDA Product Code

• OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

[00811382038952]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-04
• Device Publish Date: 2023-04-26

On-Brand Devices [NovoHip Total Hip System]

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