FDA.reportPublic FDA data

SchureMed

Primary DI
00810014600079
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0165
Catalog number
800-0165
Device description
HEAD REST ASSEMBLY
Published
2019-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810014600079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014600079008100146000798100146000790810014600079

GMDN Terms#

Term, Definition table
TermDefinition
Operating/examination/treatment table headrestA device designed to be attached to an operating/examination/treatment table to support the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest typically made of metal and synthetic materials that incorporate a cushion or pad that provides a softer surface for the patient's head to rest upon. It is available in various shapes and sizes and will typically include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7819827000LISA@SCHUREMED.COM

Regulatory Flags#

DUNS number
964322929
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
00810014600154SchureMed800-0039800-00392019-02-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
07640152573989FISSOBaitella AGFWZ2025-10-13
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
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
04250407786663FENTEXFENTEX medical GmbHFWZ2024-12-28
04250407786670FENTEXFENTEX medical GmbHFWZ2024-12-28
10197344072033MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
10197344120802MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28
00615521015299ALLENHILL-ROM, INC.FWZ2023-05-31
00615521014476ALLENHILL-ROM, INC.FWZ2023-05-30