T7Plus 0416-801-100

GUDID 37613327465892

Hood with Peel Away Face Shield

STRYKER CORPORATION

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use
Primary Device ID37613327465892
NIH Device Record Keyb8278274-d313-4bac-bbc6-a18b7192f565
Commercial Distribution StatusIn Commercial Distribution
Brand NameT7Plus
Version Model Number0416-801-100
Catalog Number0416-801-100
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0018002533210
Emailinst.stryker.cs@stryker.com
Phone+0018002533210
Emailinst.stryker.cs@stryker.com
Phone+0018002533210
Emailinst.stryker.cs@stryker.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327465891 [Primary]
GS107613327465891 [Primary]
GS107613327465891 [Primary]
GS137613327465892 [Package]
Contains: 07613327465891
Package: pack [28 Units]
In Commercial Distribution
GS137613327465892 [Package]
Contains: 07613327465891
Package: pack [28 Units]
In Commercial Distribution
GS137613327465892 [Package]
Contains: 07613327465891
Package: pack [28 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXYHOOD, SURGICAL
FXYHOOD, SURGICAL
FXYHOOD, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [T7Plus]

37613327466707Hood
37613327466134Zippered Toga with Peel Away Face Shield
37613327466103Zippered Toga with Peel Away
37613327466073Pullover Toga
37613327466066Pullover Toga
37613327466028Zippered Toga with Peel Away Face Shield
37613327466011Zippered Toga with Peel Away Face Shield
37613327465991Pullover Toga
37613327465984Zippered Toga
37613327465960Pullover Toga
37613327465908Zippered Toga
37613327465892Hood with Peel Away Face Shield
37613327465885Hood with Standard Face Shield
37613327465793Zippered Toga
37613327466110Zippered Toga

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