FDA.reportPublic FDA data

NA

Primary DI
07613153064749
Brand
NA
Company
STRYKER CORPORATION
Model
0290100030
Catalog number
0290-100-030
Device description
SinuFlow Cannula
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAMCANNULA, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613153064749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613153064749076131530647497613153064749

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic irrigation/aspiration cannulaA rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252254430VertaPlex04066220000406-622-0002016-09-23
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348811099099INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
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00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
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00194613102364MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102388MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107444MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
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00194613108571MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102746MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
10080196392278MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
10888277371774MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20080196392275MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20888277371771MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250676742360Suction tubeSpiggle & Theis Medizintechnik GmbHKAM2024-12-27
08904461006835OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006842OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03