FDA.reportPublic FDA data

T7Plus

Primary DI
37613327466707
Brand
T7Plus
Company
STRYKER CORPORATION
Model
0416-801-200
Catalog number
0416-801-200
Device description
Hood
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200493000Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverStryker Corporation2020-03-21FXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327466707PackageGS128In Commercial Distribution
07613327466706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332746670737613327466707
07613327466706076133274667067613327466706

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn 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 Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0018002533210inst.stryker.cs@stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

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
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
07613252661085Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661079Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23
37613252661086Flyte, SurgiCoolSTRYKER CORPORATIONFXY2016-09-23