Burlington Industries 7905

GUDID 00850057346411

Surgical Gown, Level 3, Size 2XL, Blue, Reuseable

Elevate Textiles, Inc.

Surgical gown, reusable
Primary Device ID00850057346411
NIH Device Record Key8958c1dd-a598-4123-8b94-4c624250f7cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurlington Industries
Version Model NumberSURGWNMAXULT03-SV-0115F-2XL
Catalog Number7905
Company DUNS825198484
Company NameElevate Textiles, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com
Phone13366841683
Emailnathaniel.terry@elevatetextiles.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850057346411 [Primary]

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


[00850057346411]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-16
Device Publish Date2024-04-08

On-Brand Devices [Burlington Industries]

00850057346404Surgical Gown, Level 3, Size XL, Blue, Reuseable
00850057346398Surgical Gown, Level 3, Size L, Blue, Reuseable
00850057346374Surgical Gown, Level 3, Size S, Blue, Reuseable
00850057346411Surgical Gown, Level 3, Size 2XL, Blue, Reuseable
00850057346381Surgical Gown, Level 3, Size M, Blue, Reuseable

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