FDA.reportPublic FDA data

Neuro Adapter

Primary DI
00863106000400
Brand
Neuro Adapter
Company
P AND G ENGINEERING INC
Model
OZ 7515575
Device description
Neuro Adapter, (US), OZ 7515575
Published
2019-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863106000400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863106000400008631060004008631060004000863106000400

GMDN Terms#

Term, Definition table
TermDefinition
ENT headrestA device designed to be attached to an appropriate operating table to support and stabilize the head of a recumbent patient during an ear/nose/throat (ENT) procedure. The headrest is typically made of metal and synthetic materials that incorporate a cup-shaped, or indented with a central hole, 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 adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
795690242
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863106000479"Knee Board, 18"" (US)"OZ 75400752019-04-16
00863106000486"Knee Board, 18"", (EU)"OZ 75400042019-04-16
00863106000424Arm & Hand Surgery Table OZ 75128752019-04-16
00863106000431Hour Glass Arm & Hand Surgery TableOZ 75167752019-04-16
00863106000417Neuro Adapter D850OZ 75206752019-04-16
00863106000448Adjustable Patient Transfer BoardOZ 75221752019-04-16
00863106000455Narrow Head RestOZ 75169752019-04-16
00863106000462Light Weight Leg Transfer Board, Sling StyleOZ 75601752019-04-16
00863106000493Neuro Adapter, (EU)OZ 75174752019-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00696588008295De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2026-04-02
00696588008301De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-04-02
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07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
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07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
10653405986379CONMEDConmed CorporationFWZ2026-01-17
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-11-21
07640152573989FISSOBaitella AGFWZ2025-10-13
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
00733657288131ATEC KIT 4 STRAPSALIMED, INC.FWZ2024-08-02
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08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
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00615521032203ALLENHILL-ROM, INC.FWZ2023-06-02
00615521015299ALLENHILL-ROM, INC.FWZ2023-05-31
00615521014476ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30