FDA.reportPublic FDA data

SURGISTAR

Primary DI
00878799002860
Brand
SURGISTAR
Company
SURGISTAR, INC.
Model
8191
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
KCJApplicator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10878799002867PackageGS16In Commercial Distribution
00878799002860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087879900286710878799002867
00878799002860008787990028608787990028600878799002860

GMDN Terms#

Term, Definition table
TermDefinition
Cotton pledget applicator, single-useA slender rod of wood, flexible metal, or synthetic material with a pledget of cotton attached at one end intended to be used for cleaning or applying a substance (e.g., medication) to superficial wounds or body orifices [e.g., ears, nose, oral cavity, throat, anus, rectum]. 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
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry FarrellASPEN SURGICAL PRODUCTS, INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze Best, LLCKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
05060259070426Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070488Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070853DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070983DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070990DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073120DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073137DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05