FDA.reportPublic FDA data

NA

Primary DI
00643169919396
Brand
NA
Company
MEDTRONIC, INC.
Model
PH-2500
Device description
HEADREST PH-2500 PASSIVE NEXFR GLBL MKT
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031885000NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXXImage-Guided Neurologics, Inc.2003-08-21HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169919396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169919396006431699193966431699193960643169919396

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796986144
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
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10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26