FDA.reportPublic FDA data

TIDI

Primary DI
00618125155187
Brand
TIDI
Company
TIDI PRODUCTS, LLC
Model
9090
Catalog number
9090
Device description
AQUILLON ONE HEAD HOLDER KIT
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWYHolder, Head, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618125155187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125155187006181251551876181251551870618125155187

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063519193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618125134724Grip-Lok3300M-NSB3300M-NSB2022-10-18
10618125192325POSEY8334WL8334WL2025-12-04
10618125192318AquaGuard50000-SMP50000-SMP2025-09-23
20618125192308Carina570-5439570-54392025-09-22
10618125187123VALO466846682025-08-29
10618125187130VALO466746672025-08-29
10618125187147VALO466646662025-08-29
80618125188716VALO100636610063662025-08-29
80618125188723VALO100636710063672025-08-29
80618125188730VALO100636810063682025-08-29
10618125189950VALO466946692025-08-29
80618125190177VALO100980810098082025-08-29
10618125190185VALO466546652025-08-29
20618125114669Sirona20809B63101202025-07-10
10618125192264Steris31780BF458 (056404-710)2025-07-01
10618125192271Steris31780 N/SBF459 (056404-709)2025-07-01
20618125192254Posey806080602024-12-23
00618125192144Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
00618125192175Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
00618125192182Grip-Lok3400L-10PK3400L-10PK2024-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640178061811pearltecPearl Technology AGIWY2025-07-28
04719879740615Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741179Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741186Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741193Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741209Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741216Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741223Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741230Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741247Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-21
04719879741162Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-11
04719879741285Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-10
04719879741261Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741278Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741292Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741308Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741315Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741322Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
04719879741339Blessing CathayBLESSING CATHAY CORPORATIONIWY2025-07-09
00810004900622Neocis Guidance SystemNEOCIS INCIWY2025-05-02
00850043319146Head StabilizerHYPERFINE RESEARCH, INC.IWY2024-12-11
06977071930014MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
06977071930069MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWY2024-06-21
00810050245487NADOMICO MED-DEVICE, LLCIWY2023-05-01
00850043319047Hyperfine Foam Head PadHyperfine Operations, Inc.IWY2023-01-25
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGIWY2023-01-05
00887761968424TL 5000/3000 – Surgical LightTRUMPF Medizin Systeme GmbH + Co. KGIWY2023-01-05
00887761972902Head-Positioning accessoriesTRUMPF Medizin Systeme GmbH + Co. KGIWY2023-01-05
00887761972957Head-Positioning accessoriesTRUMPF Medizin Systeme GmbH + Co. KGIWY2023-01-05