NEOFACE

GUDID 07898624865586

Paulus Miniplate 8 mm

Neoortho Produtos Ortopédicos S/A.

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07898624865586
• NIH Device Record Key: 9e310019-953f-4354-8245-3c3daba23a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOFACE
• Version Model Number: 922.098
• Company DUNS: 914644351
• Company Name: Neoortho Produtos Ortopédicos S/A.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br
• Phone: +554135351000
• Email: sac@neoortho.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898624865586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102641

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

[07898624865586]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-23

On-Brand Devices [NEOFACE]

• 07899893200641: 8-Hole Straight Reconstruction Plate
• 07898624866798: 22-Hole Angled Reconstruction Plate
• 07898624866781: 5x22-Hole Right Long Reconstruction Plate
• 07898624866774: 5x22-Hole Left Long Reconstruction Plate
• 07898624866767: 5x22x5-Hole Reconstruction Plate
• 07898624866750: 5x11-Hole Right Reconstruction Plate
• 07898624866743: 5x11-Hole Left Reconstruction Plate
• 07898624866736: 4x17-Hole Right Reconstruction Plate
• 07898624866729: 4x17-Hole Left Reconstruction Plate
• 07898624866712: 4x9-Hole Right Reconstruction Plate
• 07898624866705: 4x9-Hole Left Reconstruction Plate
• 07898624866699: 4x17x4 Reconstruction Plate
• 07898624866675: 17-Hole Reconstruction Plate
• 07898624866668: 16-Hole Straight Reconstruction Plate
• 07898624866651: 8-Hole Straight Reconstruction Plate
• 07898624866644: 6-Hole Straight Reconstruction Plate
• 07898624866149: L Extra Long Locking Fine 2.0 Miniplate
• 07898624866125: 6-Hole Extra Long Locking Hard Miniplate
• 07898624866118: 6-Hole Long Locking Hard Miniplate
• 07898624866101: 6-Hole Locking Hard Miniplate
• 07898624866095: 4-Hole Extra Long Locking Hard Miniplate
• 07898624866088: 4-Hole Long Locking Hard Miniplate
• 07898624866071: 4-Hole Locking Hard Miniplate
• 07898624866064: 2-Hole Medium Locking Fine 2.0 Miniplate
• 07898624866057: 8-Hole Medium Locking Fine 2.0 Miniplate
• 07898624866040: 8-Hole Regular Locking Fine 2.0 Miniplate
• 07898624866033: 6-Hole Extra Long Locking Fine 2.0 Miniplate
• 07898624866026: 6-Hole Long Locking Fine 2.0 Miniplate
• 07898624866019: 6-Hole Medium Locking Fine 2.0 Miniplate
• 07898624866002: 6-Hole Regular Locking Fine 2.0 Miniplate
• 07898624865999: 4-Hole Extra Long Locking Fine 2.0 Miniplate
• 07898624865982: 4-Hole Long Locking Fine 2.0 Miniplate
• 07898624865975: 4-Hole Regular Locking Fine 2.0 Miniplate
• 07898624865968: 4-Hole Medium Locking Fine 2.0 Miniplate
• 07898624865951: T 110° T Double-sided Extra Long Miniplate 18.5 mm
• 07898624865944: T 110° T Double-sided Extra Long Miniplate
• 07898624865937: T 110° T Double-sided Long Miniplate
• 07898624865920: T 110° T Double-sided Medium Miniplate
• 07898624865913: 3x2 L Double-sided Medium Miniplate
• 07898624865906: L Double-sided Extra Long Miniplate 18.5
• 07898624865890: L Double-sided Extra Long Miniplate
• 07898624865883: L Double-sided Long Miniplate
• 07898624865869: L Double-sided Medium Miniplate
• 07898624865852: L Double-sided Regular Miniplate
• 07898624865845: Sagittal Extra Long Miniplate 18.5
• 07898624865838: Sagittal Extra Long Miniplate
• 07898624865807: Sagittal Long Miniplate
• 07898624865791: Sagittal Medium Miniplate
• 07898624865784: Chin Miniplate 15 mm
• 07898624865777: Chin Miniplate 13 mm