FDA.reportPublic FDA data

Speedy Flap

Primary DI
08809265156147
Brand
Speedy Flap
Company
Jeil Medical Corporation
Model
SF-12F
Published
2015-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K130447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130447000SPEEDY FLAP SYSTEMJeil Medical Corporation2014-12-22GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809265156147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809265156147088092651561478809265156147

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.

Regulatory Flags#

DUNS number
688811603
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800089479450ARIX System Bone Screw35N-SO-L20-TA2026-06-01
08800089479467ARIX System Bone Screw35N-SO-L22-TA2026-06-01
08800089479474ARIX System Bone Screw35N-SO-L24-TA2026-06-01
08800089479481ARIX System Bone Screw35N-SO-L26-TA2026-06-01
08800089479498ARIX System Bone Screw35N-SO-L28-TA2026-06-01
08800089479504ARIX System Bone Screw35N-SO-L30-TA2026-06-01
08800089479511ARIX System Bone Screw35N-SO-L32-TA2026-06-01
08800089479528ARIX System Bone Screw35N-SO-L34-TA2026-06-01
08800089479535ARIX System Bone Screw35N-SO-L36-TA2026-06-01
08800089479542ARIX System Bone Screw35N-SO-L38-TA2026-06-01
08800089479559ARIX System Bone Screw35N-SO-L40-TA2026-06-01
08800089479566ARIX System Bone Screw35N-SO-L42-TA2026-06-01
08800089479573ARIX System Bone Screw35N-SO-L44-TA2026-06-01
08800089479580ARIX System Bone Screw35N-SO-L46-TA2026-06-01
08800089479597ARIX System Bone Screw35N-SO-L48-TA2026-06-01
08800089479603ARIX System Bone Screw35N-SO-L50-TA2026-06-01
08800089479610ARIX System Bone Screw35N-SO-L52-TA2026-06-01
08800089479627ARIX System Bone Screw35N-SO-L56-TA2026-06-01
08800089479634ARIX System Bone Screw35N-SO-L60-TA2026-06-01
08800089479641ARIX System Bone Screw40N-SA-020-T2026-06-01

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