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
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14710961934766Silicone Penrose Straight Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBP2021-12-15
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