CirFIX® Cranial bone fixation system: Flap Fixator 9903.0001.15S

GUDID 14717002404165

Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile

OSSAWARE BIOTECH CO., LTD.

Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip

• Primary Device ID: 14717002404165
• NIH Device Record Key: d92a5041-42a6-4364-a215-a873cedba602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CirFIX® Cranial bone fixation system: Flap Fixator
• Version Model Number: 9903.0001.15S
• Catalog Number: 9903.0001.15S
• 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
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM
• Phone: +88647980819
• Email: FDA@CUSMED.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04717002404168 [Primary]
GS1	14717002404165 [Package]; Contains: 04717002404168; Package: Delivery box [8 Units]; In Commercial Distribution
GS1	24717002404162 [Package]; Contains: 04717002404168; Package: Shipping carton [32 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

Devices Manufactured by OSSAWARE BIOTECH CO., LTD.

• 14717002404387 - CUSMED FACE MASK: 2021-03-31 3 Ply - Disposable High Filtration Face Mask • Face Mask Size: 175mm x 95mm (± 5 mm) • Non - sterile, single use
• 14717002404165 - CirFIX® Cranial bone fixation system: Flap Fixator: 2020-10-06Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile
• 14717002404165 - CirFIX® Cranial bone fixation system: Flap Fixator: 2020-10-06 Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile
• 14717002404172 - CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS): 2020-10-06 Flap Fixator, Low Profile Replaceable Type, PEEK, D15mm, Sterile (3 PCS)
• 14717002404325 - CirFIX® Cranial bone fixation system: Burr Hole Cover: 2020-10-06 CirFIX® Burr Hole Cover, Radiolucent Revisable Type, PEEK, 14mm/11mm, Sterile
• 04717002404335 - CirFIX® Cranial bone fixation system: Burr Hole Cover: 2020-09-22 CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP, PEEK, 14mm/11mm, Sterile