FDA.reportPublic FDA data

GUARDIAN™

Primary DI
05415067030290
Brand
GUARDIAN™
Company
ST. JUDE MEDICAL, INC.
Model
6015
Catalog number
6015
Device description
Screw, 5mm, Burr Hole Cover
Published
2018-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K181382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181382000GuardianTM Burr Hole Cover SystemSt Jude Medical2018-07-20GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067030297PackageGS15In Commercial Distribution
05415067030290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506703029715415067030297
05415067030290054150670302905415067030290

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08
05415067052780Epic™EELT-27MEELT-27M2026-07-08
05415067052797Epic™ESP300-25ESP300-252026-07-08
05415067052803Epic™ESP300-19ESP300-192026-07-08
05415067052810Epic™EELT-19AEELT-19A2026-07-08
05415067052827Epic™EELT-29MEELT-29M2026-07-08
05415067052834Epic™EELT-27AEELT-27A2026-07-08
05415067052858Epic™EELT-25AEELT-25A2026-07-08
05415067052865Epic™EELT-21AEELT-21A2026-07-08
05415067052872Epic™EELT-33MEELT-33M2026-07-08

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
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061733Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809399740946Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399740953Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745231Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745248Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745255Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745279Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745286Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061535Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061689Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061696Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061702Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061719Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061726Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13