Opti-Gard

Primary DI
00850017419322
Brand
Opti-Gard
Company
DUPACO, INC.
Model
D28200CE-Brazil
Catalog number
D28200CE-Brazil
Device description
Opti-Gard SMALL CE NON-STERILE PACK, BRAZIL
Published
2020-10-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWSShield, eye, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWSShield, Eye, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017419329PrimaryGS10
00850017419322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001741932910850017419329
00850017419322008500174193228500174193220850017419322

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, single-useA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)758-4550dly@dupacoinc.com

Regulatory Flags#

DUNS number
093616555
Device count
25
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
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
10850017419039Opti-GardD28200CED28200CE2020-10-30
10850017419046Opti-GardD28300CED28300CE2020-10-30
10850017419053Opti-GardD28300FD28300F2020-10-30
10850017419060Opti-GardD28310D283102020-10-30
10850017419077Opti-GardD28400D284002020-10-30
10850017419084Opti-GardD29400D294002020-10-30
10850017419107ProneViewD28507CED28507CE2020-10-30
10850017419114ProneViewD28505CED28505CE2020-10-30
10850017419121ProneViewD28503CED28503CE2020-10-30
10850017419138ProneViewD28600D286002020-10-30
10850017419145ProneViewD28630D286302020-10-30
10850017419152ProneViewD28701D287012020-10-30
10850017419169ProneViewD28621D286212020-10-30
10850017419176ProneViewD28655D286552020-10-30
10850017419183ProneViewD28707D287072020-10-30
10850017419190ProneViewD28706D287062020-10-30
10850017419312ProneViewD29720D297202020-10-30
10850017419329Opti-GardD28200CE-BrazilD28200CE-Brazil2020-10-30
10850017419336Opti-GardD28300CE-BrazilD28300CE-Brazil2020-10-30
20850017419128ProneViewD28503CE-60D28503CE-602020-10-30

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