FDA.reportPublic FDA data

SchureMed

Primary DI
00810014600796
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0164-SKY
Catalog number
800-0164-SKY
Device description
SHOULDER CHAIR DISPOSABLE FACE MASK 12/CS
Published
2019-06-13
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
true

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
00810014600796PrimaryGS10
00810014600161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014600796008100146007968100146007960810014600796
00810014600161008100146001618100146001610810014600161

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
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
10653405986379CONMEDConmed CorporationFWZ2026-01-17
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
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
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
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014650ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014803ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014810ALLENHILL-ROM, INC.FWZ2023-05-30
00615521031459ALLENHILL-ROM, INC.FWZ2023-05-30