FDA.reportPublic FDA data

SchureMed

Primary DI
00810014600154
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0039
Catalog number
800-0039
Device description
DISPOSABLE HEAD & CHIN STRAPS (12/CS)
Published
2019-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTKStrap, Head, Gas Mask
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01810014600153PackageGS11Not in Commercial Distribution
00810014600154PrimaryGS10
00810014600147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01810014600153018100146001531810014600153
00810014600154008100146001548100146001540810014600154
00810014600147008100146001478100146001470810014600147

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, single-useA rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-982-7000lisa@schuremed.com

Regulatory Flags#

DUNS number
964322929
Device count
12
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810014600178SchureMed539-0019 and 539-0018800-01642019-03-12
00810014602967SchureMed800-0164800-01642021-05-10
00810014602981SchureMed800-0164-ST2021-06-07
00810014602998SchureMed800-0164-T2021-06-07
00810014603001SchureMed800-0164-T-INT2021-06-07
00810057374302SchureMed800-0369-SKY3-040-222025-10-29
00810014602974SchureMed800-0164-SKY3-040-33-12019-06-13
00810014602585SchureMed800-0039-B2021-03-31
00810014602943SchureMed800-00392021-03-31
00810014603841SchureMed800-03692021-03-31
10841736116910SchureMed800-0039-SKY2021-03-31
00810014600642SchureMed800-0039-SKY800-0039-SKY2019-06-13
00810014601267SchureMed800-0039-M800-0039-M2019-06-13
00810014600277SchureMed508-1345508-13452019-06-11
00810014600444SchureMed800-0039-ST800-0039-ST2019-06-11
00810014600598SchureMed800-00153-040-242025-10-29
00810014600666SchureMed800-00893-040-20-182025-10-29
00810014600833SchureMed800-03113-040-122025-10-29
00810014602714SchureMed800-0091-SKY3-040-20-162025-10-29
00810057372100SchureMed800-03703-041-012025-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109691CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-09-09
00840319759325Hayden MedicalHayden Medical, Inc.FWZ2026-08-27
00840319759332Hayden MedicalHayden Medical, Inc.FWZ2026-08-25
00843059127331LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FWZ2026-07-20
00696588008394De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-06-23
00848530109080CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-06-04
00848530109103CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-06-04
00848530085902CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2025-11-12
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
B382SD40090530Surgical DirectSurgical Direct, Inc.FWZ2025-08-05
04250407786663FENTEXFENTEX medical GmbHFWZ2024-12-28
04250407786670FENTEXFENTEX medical GmbHFWZ2024-12-28
10197344072033MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
10197344120802MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
00848530088743HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530080396HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530098247CPAP MasksSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530098254CPAP MasksSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530099015Chin StrapSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530100292HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-30
00848530080372Chin StrapSunset Healthcare Solutions, Inc.BTK2024-07-29
00848530090777Chin StrapSunset Healthcare Solutions, Inc.BTK2024-07-29
00848530090784Chin StrapSunset Healthcare Solutions, Inc.BTK2024-07-29
00850035116388Chin StrapSunset Healthcare Solutions, Inc.BTK2024-07-25
00848530091507HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-23
00848530080365CPAP Headgear ChinSunset Healthcare Solutions, Inc.BTK2024-07-15
00848530091491HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-15