FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018739023PrimaryGS10
00850018739030PrimaryGS10
00850018739009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018739023008500187390238500187390230850018739023
00850018739030008500187390308500187390300850018739030
00850018739009008500187390098500187390090850018739009

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850018739044Primera Medical SuppliesFACE SHIELD-YFACE SHIELD-Y2020-08-07
00850018739023Primera Medical SuppliesFACE SHIELD-BFACE SHIELD-B2020-05-01
00850018739030Primera Medical SuppliesFACE SHIELDFACE SHIELD2020-05-01
00850018739047Primera Medical SuppliesFACE SHIELD-YFACE SHIELD-Y2020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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10097604245101Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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