FDA.reportPublic FDA data

NA

Primary DI
00810050242134
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9007
Device description
STRAP, FOREHEAD W/ADULT PAD. Includes: 9007-A - PAD, FOREHEAD .50” x 2” x 6” (00810050241434), 9007-B - STRAP, FOREHEAD, 2” x 23” (00810050242127)
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00810050242134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050242134008100502421348100502421340810050242134

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
10810050245446NA60002023-10-13
00810050245494NA2822023-10-13
00810050245470NA169-202023-05-01
00810050245487NA2-UF2023-05-01
00810050240840NA1592020-06-11
00810050243148NA128-UF2020-08-12
00810050245289NA1632022-05-27
00810050245302NA142-202022-05-27
00810050245456NA303-UF2022-11-18
00810050245432NA209-202022-11-10
00810050245401NA333502022-10-31
00810050245425NA108-82022-10-25

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