FDA.reportPublic FDA data

Flyte, SurgiCool

Primary DI
07613252661085
Brand
Flyte, SurgiCool
Company
STRYKER CORPORATION
Model
0408801500
Catalog number
0408801500
Device description
Peel-Away Hood
Published
2016-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXYHOOD, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXYHood, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613252661086PackageGS128In Commercial Distribution
07613252661085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761325266108637613252661086
07613252661085076132526610857613252661085

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature049 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
00850024195134MOLLIMS-00009MM10122022-06-27
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327624069EchoECHO100100-01ECHO100100-012025-01-24
07613327624083EchoECHO100105-01ECHO100105-012025-01-24
07613327624106Broadway 8BRW084132-01BRW084132-012025-01-24
07613327561210Stroke Fast PackAXS2PK07404601AXS2PK074046012023-07-14
07613327561227Stroke Fast PackAXS2PK07104601AXS2PK071046012023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09009607815001ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
19009607815008ViVi PEEL-OFF HOODTHI Total Healthcare Innovation GmbHFXY2025-06-10
07613327625172Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625189Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
07613327625233Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625173Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625180Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
37613327625234Steri-ShieldSTRYKER CORPORATIONFXY2025-02-21
09009607801004ViVi HelmetTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607801301ViVi Helmet HPLTHI Total Healthcare Innovation GmbHFXY2023-11-10
09009607812000ViVi HoodTHI Total Healthcare Innovation GmbHFXY2023-11-10
07613327465860T7STRYKER CORPORATIONFXY2020-05-11
07613327465884T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327465891T7PlusSTRYKER CORPORATIONFXY2020-05-11
07613327466683T7STRYKER CORPORATIONFXY2020-05-11
07613327466706T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465861T7STRYKER CORPORATIONFXY2020-05-11
37613327465885T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327465892T7PlusSTRYKER CORPORATIONFXY2020-05-11
37613327466684T7STRYKER CORPORATIONFXY2020-05-11
37613327466707T7PlusSTRYKER CORPORATIONFXY2020-05-11
50192253018774CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
50192253018781CARDINAL HEALTHCardinal Health 200, LLCFXY2019-06-26
20885380019811CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
50885380019812CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
50630140927162CARDINAL HEALTHCardinal Health 200, LLCFXY2018-12-20
07613252661078Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661079Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661086Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23