FDA.reportPublic FDA data

CirFIX® Cranial bone fixation system: Burr Hole Cover

Primary DI
14717002404325
Brand
CirFIX® Cranial bone fixation system: Burr Hole Cover
Company
OSSAWARE BIOTECH CO., LTD.
Model
9905.0014.11S
Catalog number
9905.0014.11S
Device description
CirFIX® Burr Hole Cover, Radiolucent Revisable Type, PEEK, 14mm/11mm, Sterile
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXRCover, Burr Hole

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192310000Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.2020-06-03GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14717002404325PackageGS112In Commercial Distribution
24717002404322PackageGS148In Commercial Distribution
04717002404328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471700240432514717002404325
2471700240432224717002404322
04717002404328047170024043284717002404328

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur hole coverA sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88647980819FDA@CUSMED.COM

Regulatory Flags#

DUNS number
656747172
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04717002404328CirFIX® Cranial bone fixation system: Burr Hole Cover9905.0014.11S9905.0014.11S2020-09-28
04717002404335CirFIX® Cranial bone fixation system: Burr Hole Cover9906.0014.11S9906.0014.11S2020-09-14
04717002404168CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
04717002404175CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28
04717002404380CUSMED FACE MASK9600.0000.002021-03-23
14717002404387CUSMED FACE MASK9600.0000.002021-03-23
14717002404165CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
14717002404172CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
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08809416061726Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13