T7 0416-850-200

GUDID 37613327465915

Zippered Toga

STRYKER CORPORATION

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use
Primary Device ID37613327465915
NIH Device Record Key66041925-511c-41de-a0c5-6ca608c6ccc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameT7
Version Model Number0416-850-200
Catalog Number0416-850-200
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
GS107613327465914 [Primary]
GS107613327465914 [Primary]
GS107613327465914 [Primary]
GS137613327465915 [Package]
Contains: 07613327465914
Package: pack [8 Units]
In Commercial Distribution
GS137613327465915 [Package]
Contains: 07613327465914
Package: pack [8 Units]
In Commercial Distribution
GS137613327465915 [Package]
Contains: 07613327465914
Package: pack [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGOWN, SURGICAL
FYAGOWN, SURGICAL
FYAGOWN, 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 [T7]

37613327466684Hood
37613327466127Zippered Toga with Peel Away Face Shield
37613327466097Zippered Toga with Peel Away Face Shield
37613327466080Zippered Toga with Peel Away Face Shield
37613327466059Zippered Toga
37613327466042Pullover Toga
37613327466004Pullover Toga
37613327465977Pullover Toga
37613327465915Zippered Toga
37613327465861Hood with Peel Away Face Shield
37613327466035Zippered Toga
37613327465953Zippered Toga with Peel Away Face Shield
37613327465946Pullover Toga
37613327465922Zippered Toga

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