Signature 42-433410

GUDID E314424334100

SIGNATURE XP BONE MODELS

Materialise NV

Custom-made organ/bone anatomy model

• Primary Device ID: E314424334100
• NIH Device Record Key: a8202689-1a5e-4a4c-8e64-17f5d79a1dab
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Signature
• Version Model Number: 42-433410
• Catalog Number: 42-433410
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E31442433410 [Previous]
HIBCC	E314424334100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140257

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[E314424334100]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-07-21

On-Brand Devices [Signature]

• E314SIGNATUREOMS0: Signature online management system
• E314SIGNATURE0: Signature Planner
• E314424334100: SIGNATURE XP BONE MODELS
• E314424227730: SIG C/T TKA GDE/MDL SET 06-08
• E314424227720: SIG C/T TKA GDE/MDL SET 06-07
• E314424227710: SIG C/T TKA GDE/MDL SET 06-05
• E314424227700: SIG C/T TKA GDE/MDL SET 06-02
• E314424227630: SIG C/T TKA GDE/MDL SET 04-08
• E314424227620: SIG C/T TKA GDE/MDL SET 04-07
• E314424227610: SIG C/T TKA GDE/MDL SET 04-05
• E314424227600: SIG C/T TKA GDE/MDL SET 04-02
• E314424227530: SIG C/T TKA GDE/MDL SET 03-08
• E314424227520: SIG C/T TKA GDE/MDL SET 03-07
• E314424227510: SIG C/T TKA GDE/MDL SET 03-05
• E314424227500: SIG C/T TKA GDE/MDL SET 03-02
• E314424225780: CT SIG TKA GDE/MDL SET 06-08
• E314424225770: CT SIG TKA GDE/MDL SET 06-07
• E314424225760: CT SIG TKA GDE/MDL SET 06-05
• E314424225750: CT SIG TKA GDE/MDL SET 06-02
• E314424225730: SIG TKA GDE/MDL SET 06-08
• E314424225720: SIG TKA GDE/MDL SET 06-07
• E314424225710: SIG TKA GDE/MDL SET 06-05
• E314424225700: SIG TKA GDE/MDL SET 06-02
• E314424225680: CT SIG TKA GDE/MDL SET 04-08
• E314424225670: CT SIG TKA GDE/MDL SET 04-07
• E314424225660: CT SIG TKA GDE/MDL SET 04-05
• E314424225650: CT SIG TKA GDE/MDL SET 04-02
• E314424225630: SIG TKA GDE/MDL SET 04-08
• E314424225620: SIG TKA GDE/MDL SET 04-07
• E314424225610: SIG TKA GDE/MDL SET 04-05
• E314424225600: SIG TKA GDE/MDL SET 04-02
• E314424225580: CT SIG TKA GDE/MDL SET 03-08
• E314424225570: CT SIG TKA GDE/MDL SET 03-07
• E314424225560: CT SIG TKA GDE/MDL SET 03-05
• E314424225550: CT SIG TKA GDE/MDL SET 03-02
• E314424225530: SIG TKA GDE/MDL SET 03-08
• E314424225520: SIG TKA GDE/MDL SET 03-07
• E314424225510: SIG TKA GDE/MDL SET 03-05
• E314424225500: SIG TKA GDE/MDL SET 03-02
• E314424224100: MRI Bone Models
• E314424115740: SIG M PKA GDE/MDL SET XLG MP
• E314424115730: SIG M PKA GDE/MDL SET LGE MP
• E314424115720: SIG M PKA GDE/MDL SET MED MP
• E314424115710: SIG M PKA GDE/MDL SET SML MP
• E314424115700: SIG M PKA GDE/MDL SET XSM MP
• E314424115640: SIG M PKA GDE/MDL SET XLG PH3
• E314424115630: SIG M PKA GDE/MDL SET LGE PH3
• E314424115620: SIG M PKA GDE/MDL SET MED PH3
• E314424115610: SIG M PKA GDE/MDL SET SML PH3
• E314424115600: SIG M PKA GDE/MDL SET XSM PH3