Merete® CS Cortical Screw Fully Threaded CR35310

GUDID 04048266133915

Merete GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04048266133915
• NIH Device Record Key: aefa1366-9659-4952-871d-7ad9a42d901f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merete® CS Cortical Screw Fully Threaded
• Version Model Number: 3.5 10
• Catalog Number: CR35310
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com

Device Dimensions

• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
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• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266133915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130400

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

[04048266133915]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-08
• Device Publish Date: 2015-10-15

On-Brand Devices [Merete® CS Cortical Screw Fully Threaded]

• 04048266135285: 3.0 12
• 04048266133960: 3.5 20
• 04048266133915: 3.5 10
• 04048266135421: TiAl6V4 ELI non-sterile
• 04048266135414: TiAl6V4 ELI non-sterile
• 04048266135407: TiAl6V4 ELI non-sterile
• 04048266135391: TiAl6V4 ELI non-sterile
• 04048266135384: TiAl6V4 ELI non-sterile
• 04048266135377: TiAl6V4 ELI non-sterile
• 04048266135360: TiAl6V4 ELI non-sterile
• 04048266135353: TiAl6V4 ELI non-sterile
• 04048266135346: TiAl6V4 ELI non-sterile
• 04048266135339: TiAl6V4 ELI non-sterile
• 04048266145888: TiAl6V4 ELI sterile
• 04048266145871: TiAl6V4 ELI sterile
• 04048266145864: TiAl6V4 ELI sterile
• 04048266145857: TiAl6V4 ELI sterile
• 04048266145840: TiAl6V4 ELI sterile
• 04048266145833: TiAl6V4 ELI sterile
• 04048266145826: TiAl6V4 ELI sterile
• 04048266145819: TiAl6V4 ELI sterile
• 04048266145802: TiAl6V4 ELI sterile
• 04048266145796: TiAl6V4 ELI sterile
• 04048266145789: TiAl6V4 ELI sterile
• 04048266145772: TiAl6V4 ELI sterile
• 04048266145765: TiAl6V4 ELI sterile
• 04048266145758: TiAl6V4 ELI sterile
• 04048266145741: TiAl6V4 ELI sterile
• 04048266145734: TiAl6V4 ELI sterile
• 04048266135322: TiAl6V4 ELI non-sterile
• 04048266135315: TiAl6V4 ELI non-sterile
• 04048266135308: TiAl6V4 ELI non-sterile
• 04048266135292: TiAl6V4 ELI non-sterile
• 04048266135278: TiAl6V4 ELI non-sterile
• 04048266134066: TiAl6V4 ELI non-sterile
• 04048266134059: TiAl6V4 ELI non-sterile
• 04048266134042: TiAl6V4 ELI non-sterile
• 04048266134035: TiAl6V4 ELI non-sterile
• 04048266134028: TiAl6V4 ELI non-sterile
• 04048266134011: TiAl6V4 ELI non-sterile
• 04048266134004: TiAl6V4 ELI non-sterile
• 04048266133991: TiAl6V4 ELI non-sterile
• 04048266133984: TiAl6V4 ELI non-sterile
• 04048266133977: TiAl6V4 ELI non-sterile
• 04048266133953: TiAl6V4 ELI non-sterile
• 04048266133946: TiAl6V4 ELI non-sterile
• 04048266133939: TiAl6V4 ELI non-sterile
• 04048266133922: TiAl6V4 ELI non-sterile
• 04048266164667: TiAl6V4 ELI non-sterile
• 04048266164650: TiAl6V4 ELI non-sterile