FDA.reportPublic FDA data

Strong Manufacturers

Primary DI
00850005354758
Brand
Strong Manufacturers
Company
Strong Medical Partners LLC
Model
5320
Catalog number
5320
Device description
Full-length, anti-fog, lightweight face shield for bodily fluid splash protection. Not for use in presence of high intensity heat source or flammable gas. Reusable, single-user recommended. Natural rubber latex in head strap.
Published
2022-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10850005354755PackageGS140In Commercial Distribution
00850005354758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000535475510850005354755
00850005354758008500053547588500053547580850005354758

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, reusableA 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
716-507-4476info@strongmanufacturers.com

Regulatory Flags#

DUNS number
062388929
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040791174Strong Manufacturers710171012022-08-19
00810757021056Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757021063Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757021070Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810757021049Sam Tell Companies75044NG4PFLG-BK2024-01-12
00810757020899Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757020905Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757020912Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810131090609Nception71014GN3042023-11-03
00810131090616Nception71012GN3022023-11-03
00810131090623Nception71013GN3032023-11-03
00810131090630Nception71015GN3052023-11-03
00810131090647Nception71044GN4042023-11-03
00810131090654Nception71042GN4022023-11-03
00810131090661Nception71043GN4032023-11-03
00810131090678Nception71045GN4052023-11-03
00810131090685Nception75042GN402B2023-11-03
00810131090692Nception75043GN403B2023-11-03
00810131090708Nception75044GN404B2023-11-03
00810131090715Nception75045GN405B2023-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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