CirFIX® Cranial bone fixation system: Burr Hole Cover 9905.0014.11S

GUDID 14717002404325

CirFIX® Burr Hole Cover, Radiolucent Revisable Type, PEEK, 14mm/11mm, Sterile

OSSAWARE BIOTECH CO., LTD.

Cranial bur hole cover

• Primary Device ID: 14717002404325
• NIH Device Record Key: 536fda5b-7acb-40e6-ae85-2ca68c5d3232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CirFIX® Cranial bone fixation system: Burr Hole Cover
• Version Model Number: 9905.0014.11S
• Catalog Number: 9905.0014.11S
• Company DUNS: 656747172
• Company Name: OSSAWARE BIOTECH CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: +88647980819
• Email: FDA@CUSMED.COM
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04717002404328 [Primary]
GS1	14717002404325 [Package]; Contains: 04717002404328; Package: Delivery box [12 Units]; In Commercial Distribution
GS1	24717002404322 [Package]; Contains: 04717002404328; Package: Shipping carton [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192310

FDA Product Code

• GXR: Cover, Burr Hole

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-06
• Device Publish Date: 2020-09-28

On-Brand Devices [CirFIX® Cranial bone fixation system: Burr Hole Cover]

• 04717002404335: CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP, PEEK, 14mm/11mm, Sterile
• 14717002404325: CirFIX® Burr Hole Cover, Radiolucent Revisable Type, PEEK, 14mm/11mm, Sterile