FDA.reportPublic FDA data

SCANCOAT

Primary DI
00810050242561
Brand
SCANCOAT
Company
DOMICO MED-DEVICE, LLC
Model
9015A
Device description
Small Child Head Rest
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
IWYHolder, Head, Radiographic
KXJTable, Radiologic
PRNPediatric Position Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1
KXJTable, RadiologicRadiology2
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050242561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050242561008100502425618100502425610810050242561

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
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
20888277668000MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
00810050245531NADOMICO MED-DEVICE, LLCIWY2024-06-21
00810050245487NADOMICO MED-DEVICE, LLCKXJ2023-05-01
G242RHIAB9Techno-AideTechno-Aide, Inc.IWY2023-02-13
00810050245463NADOMICO MED-DEVICE, LLCKXJ2023-01-13
10810087350861CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351110CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351165CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351196CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351240CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351349CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351356CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351363CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351370CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351677CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351684CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351691CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351707CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351714CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351721CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351899CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351905CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351912CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351929CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351936CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351943CoulmedCoulmed Products Group LLCPRN2023-01-06