FDA.reportPublic FDA data

MAYFIELD®

Primary DI
10381780256663
Brand
MAYFIELD®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
GS115
Device description
"BUTTON HEAD SCREW 6-32 X 1/4"""
Published
2016-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
HBMHEADREST, NEUROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2
HBMHeadrest, NeurosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780256663PrimaryGS10
M268GS1151SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178025666310381780256663

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction system, brainA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
963856096
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344667Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344674Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344681Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344698Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344704Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344711Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344728Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344735Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344742Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344759Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780267423MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-11
10381780267454MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267485MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267577MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267652MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267744MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267904MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267935MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-05-03
10381780267416MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19
10381780267430MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19
10381780267447MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19
10381780267478MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19
10381780267560MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19
10381780267645MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBM2018-04-19