FDA.reportPublic FDA data

SURGISTAR

Primary DI
00878799008077
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
501030
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSNFilter, Conduction, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSNFilter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10878799008074PackageGS150In Commercial Distribution
00878799008077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087879900807410878799008074
00878799008077008787990080778787990080770878799008077

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid/gas irrigatorA sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
17605982480CUSTOMERSERVICE@SURGISTAR.COM

Regulatory Flags#

DUNS number
808865125
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00878799004925Surgistar1051572021-05-20
10878799004922Surgistar1051572021-05-20
00878799003072Surgistar9400122021-02-24
00878799003140Surgistar1920012021-02-24
00878799003317Surgistar7889152021-02-24
00878799003324Surgistar7891152021-02-24
00878799003355Surgistar8818492021-02-24
00878799003362Surgistar8822492021-02-24
00878799003379Surgistar8824492021-02-24
00878799003386Surgistar8840222021-02-24
00878799003393Surgistar8822392021-02-24
00878799003416Surgistar9603502021-02-24
00878799003423Surgistar9603002021-02-24
00878799003447Surgistar8855852021-02-24
00878799003454Surgistar9655852021-02-24
00878799004895Surgistar9400112021-02-24
00878799004901Surgistar1250082021-02-24
00878799004918Surgistar1251792021-02-24
00878799004932Surgistar126-MINDE-1.3A2021-02-24
00878799004949Surgistar126-MINDE-1.3AD2021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223120316FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223069585MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301411Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301442Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301565Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301688Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306881Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306904Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306980Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301435Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301459Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301572Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301695Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302289Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302265Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302104Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306911Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223049877FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
04048223050064FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
14048223031312NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
14048223041793Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223031315NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
15019315107283PortexICU MEDICAL, INC.BSN2020-06-22
35019315107287PortexSmiths Medical Czech Republic a.s.BSN2020-06-22
15019517054651PortexICU MEDICAL, INC.BSN2020-03-09