FDA.reportPublic FDA data

StimlocTM

Primary DI
20613994292791
Brand
StimlocTM
Company
MEDTRONIC, INC.
Model
DB-5000
Device description
Accy Kit DB-5000 Stimloc Cam ZA
Published
2017-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K001096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001096000BURR HOLE COVER, MODEL XXImage-Guided Neurologics, Inc.2000-10-25GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994292791PrimaryGS10
00613994292797Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399429279120613994292791
00613994292797006139942927976139942927970613994292797

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical headrestA device designed to be attached to an appropriate operating table to support and immobilize the head of a recumbent patient during a neurosurgical procedure. The headrest is typically made of metal and synthetic materials that incorporate a semicircular cupped cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustment to facilitate surgeon access to the skull. This device may be attached to dedicated chairs used for neurosurgical procedures. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-34 Degrees Celsius57 Degrees Celsius
Storage Environment Temperature-30 Degrees Fahrenheit135 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
796986144
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

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