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
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

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