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.
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| 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 |
| 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 | 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 |
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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