FDA.report

Primera Medical Supplies

Primary DI
00850018739009
Brand
Primera Medical Supplies
Company
PRIMERA PLASTICS, INC.
Model
FACE SHIELD-B
Catalog number
FACE SHIELD-B
Device description
Disposable Face Shield - 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
00850018739023PrimaryGS10
00850018739030PrimaryGS10
00850018739009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018739023008500187390238500187390230850018739023
00850018739030008500187390308500187390300850018739030
00850018739009008500187390098500187390090850018739009

GMDN Terms

TermDefinition
Eye splash shield, single-useA non-sterile 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.

Sterilization Methods

Method

Contacts

PhoneEmail
6167486248Customerservice@primera-inc.com

Regulatory Flags

DUNS number
836290700
Device count
96
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850018739047Primera Medical SuppliesFACE SHIELD-YFACE SHIELD-Y2020-08-07

Other Devices Sharing Product Codes

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