FDA.reportPublic FDA data

SchureMed

Primary DI
00810014601243
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0098-M (ONE OF TEN)
Device description
URO-TRAPPER DRAIN BAGS, STERILE
Published
2020-04-14
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
00810014601243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014601243008100146012438100146012430810014601243

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tissue/fluid collection bag, sterileA sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. 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
1
Premarket exempt
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
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
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
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014650ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014803ALLENHILL-ROM, INC.FWZ2023-05-30