FDA.reportPublic FDA data

MAYFIELD®

Primary DI
10381780253730
Brand
MAYFIELD®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
A2012P
Device description
POOL - UNIVERSAL BRAIN RETRACTOR SYSTEM
Published
2016-07-26
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
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780253730PrimaryGS10
M268A2012P1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178025373010381780253730

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
Lot or batch
true
Serial number
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
00190776420406MillenniumAvalign Technologies, Inc.GZT2026-08-26
00190776417239MillenniumAvalign Technologies, Inc.GZT2026-08-19
00190776416997MillenniumAvalign Technologies, Inc.GZT2026-08-18
00724995355296V. MuellerSteris CorporationGZT2026-08-18
00724995355319V. MuellerSteris CorporationGZT2026-08-18
00724995355340V. MuellerSteris CorporationGZT2026-08-18
00724995355364V. MuellerSteris CorporationGZT2026-08-18
00724995355388V. MuellerSteris CorporationGZT2026-08-18
00190776408756MillenniumAvalign Technologies, Inc.GZT2026-08-03
00190776402167MillenniumAvalign Technologies, Inc.GZT2026-07-21
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
00860003476802MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476819MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00860003476826MindsEye Expandable PortPharaoh Neuro, Inc.GZT2022-04-18
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
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