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| 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 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| FDA@CUSMED.COM | |
| Phone | +88647980819 |
| 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 | 14717002404653 [Package] Contains: 04717002404168 Package: Delivery box [12 Units] In Commercial Distribution |
| GS1 | 24717002404162 [Package] Contains: 04717002404168 Package: Shipping carton [32 Units] In Commercial Distribution |
| GS1 | 24717002404650 [Package] Contains: 04717002404168 Package: Shipping carton [60 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 |
Trademark Results [CirFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CIRFIX 87203114 5315012 Live/Registered |
OSSAWARE BIOTECH CO., LTD. 2016-10-14 |
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