OSSDSIGN Cranioplug n/a

GUDID 07350086550221

OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)

Ossdsign AB

Cranial bur hole cover

• Primary Device ID: 07350086550221
• NIH Device Record Key: 91d08053-94b7-4249-9bab-32d104708bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSDSIGN Cranioplug
• Version Model Number: 14 mm, 2 fixation-points
• Catalog Number: n/a
• Company DUNS: 350354370
• Company Name: Ossdsign AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
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• Outer Diameter: 14 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Outer Diameter: 14 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 93 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350086550221 [Primary]
GS1	17350086550228 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	27350086550225 [Package]; Package: Envelope [1 Units]; In Commercial Distribution

FDA Product Code

• GXR: Cover, Burr Hole

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-01
• Device Publish Date: 2019-06-05

On-Brand Devices [OSSDSIGN Cranioplug]

• 17350086550259: OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titan
• 17350086550242: OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titan
• 17350086550235: OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titan
• 07350086550221: OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titan