FDA.reportPublic FDA data

Cyclone

Primary DI
00857326005499
Brand
Cyclone
Company
STRYKER CORPORATION
Model
CC-100
Device description
Sinonasal Suction and Irrigation System
Published
2020-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBPCatheter, Multiple Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBPCatheter, Multiple LumenGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005496PackageGS11In Commercial Distribution
00857326005499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600549610857326005496
00857326005499008573260054998573260054990857326005499

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14710961934773Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
14710961934780Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934769Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934776Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
04710961934783Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
14710961934759Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-11-22
04710961934752Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-11-22
08034139296494Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
08034139296517Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
08034139296678Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
08034139296685Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
08034139297309Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139296491Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139296514Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
18034139296675Smart Drain Round Coaxial Drain Fr 24REDAX SPAGBP2021-05-07
18034139296682Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
18034139297306Smart Drain Round Coaxial Drain Fr 28REDAX SPAGBP2021-05-07
00827002362246CookCOOK INCORPORATEDGBP2020-10-02