FDA.report

Latitude™

Primary DI
50009336009935
Brand
Latitude™
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
32031693
Catalog number
32031693
Device description
Latitude Protective Face Shield (not anti-fog)
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50009336009935PrimaryGS10
00009336009930Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5000933600993550009336009935
00009336009930000093360099300093360099300009336009930

GMDN Terms

TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.669.6905info@vermed.com

Regulatory Flags

DUNS number
002111896
Device count
400
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00009336002597VermedLWG-3090029/5ALWG-3090029/5A2017-05-02
00009336002603VermedLWG-2090029GR LWG-2090029GR 2016-09-24
00009336002610VermedLWG-2090029RDLWG-2090029RD2016-09-24
00009336002627VermedLWG-2090029WH LWG-2090029WH 2016-09-24
00009336002665VermedLWG-2090029/3A LWG-2090029/3A 2016-09-24
00009336002672VermedLWG-2090029/5ALWG-2090029/5A2016-09-24
00009336002689VermedLWG-2090029BK LWG-2090029BK 2016-09-24
00009336002696VermedLWG-2090029BR LWG-2090029BR 2016-09-24
00009336002795VermedLWG-3300051/5ALWG-3300051/5A2016-09-24
00009336002863VermedLWG-3300029/5ALWG-3300029/5A2016-09-24
00009336002870VermedLWG-3300029/5AT LWG-3300029/5AT 2016-09-24

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