FDA.reportPublic FDA data

N/A

Primary DI
00810050243209
Brand
N/A
Company
DOMICO MED-DEVICE, LLC
Model
9008
Device description
KIT, ADULT HEAD REST. Includes: 9008A - REST, ADULT MEDIUM HEAD (00810050242455), 9008B - REST, ADULT LARGE HEAD (00810050241717)
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
IWYHolder, Head, Radiographic
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
IWYHolder, Head, RadiographicRadiology1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050243209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050243209008100502432098100502432090810050243209

GMDN Terms#

Term, Definition table
TermDefinition
Multifunction body cushionA soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050241618NAVMR33PUBB2020-09-24
00810050243483NA90192020-09-24
00810050241120NAVMR38X012020-09-24
00810050242462NA9012-A2020-09-24
00810050242479N/A9012-B2020-09-24
00810050242486NA9012-C2020-09-24
00810050242493N/A9012-D2020-09-24
00810050242509NA9013-A2020-09-24
00810050242516N/A9013-B2020-09-24
00810050242523NA9013-C2020-09-24
00810050242530N/A9013-D2020-09-24
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
00810050245548NA60012024-12-31
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05