FDA.reportPublic FDA data

Clear Choice

Primary DI
00620974002864
Brand
Clear Choice
Company
Southmedic Incorporated
Model
SMI9211MC
Catalog number
SMI9211MC
Device description
Frames
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10620974002861PrimaryGS10
00620974002864Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400286110620974002861
00620974002864006209740028646209740028640620974002864

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(705)726-9383custserv@southmedic.com

Regulatory Flags#

DUNS number
246848147
Device count
100
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
true
Expiration date on label
false
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
10620974001338Southmedic Instrument Cleaning BrushesPK45DS01PK45DS012026-01-07
10620974004506Southmedic Instrument Cleaning BrushesPK45DS02PK45DS022026-01-07
10620974004513Southmedic Instrument Cleaning BrushesPK45DS03PK45DS032026-01-07
10620974004520Southmedic Instrument Cleaning BrushesPK45DS04PK45DS042026-01-07
10620974004537Southmedic Instrument Cleaning BrushesPK45DS05PK45DS052026-01-07
00620974004288BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
00620974004325Southmedic Instrument Cleaning BrushesPK45602PK456022025-08-28
00620974004332Southmedic Instrument Cleaning BrushesPK45603PK456032025-08-28
00620974004349Southmedic Instrument Cleaning BrushesPK45604PK456042025-08-28
00620974004356Southmedic Instrument Cleaning BrushesPK45605PK456052025-08-28
00620974004363Southmedic Instrument Cleaning BrushesPK45606PK456062025-08-28
00620974004370Southmedic Instrument Cleaning BrushesPK45620PK456202025-08-28
00620974004387Southmedic Instrument Cleaning BrushesPK459000PK4590002025-08-28
00620974004394Southmedic Instrument Cleaning BrushesPKM16XFirmPKM16XFirm2025-08-28
00620974004424Ecobase Foam Spray11050-Foam-1211050-Foam-122025-07-18
00620974004301Scope Sweeper Dual Action Endoscope Cleaning BrushesHZ2842+120+0+2200HZ2842+120+0+22002025-05-30
00620974004318Scope Sweeper Dual Action Endoscope Cleaning BrushesHZ2842+120+SB+2200HZ2842+120+SB+22002025-05-30
00620974004219Scope Sweeper Dual Action Endoscope Cleaning BrushesHZ2842+1+SPUP+2200/NSHZ2842+1+SPUP+2200/NS2025-04-24
00620974004226Scope Sweeper Dual Action Endoscope Cleaning BrushesHZ2842+1+SPUP+2200HZ2842+1+SPUP+22002025-04-24
00620974004233Scope Sweeper Dual Action Endoscope Cleaning BrushesHZ2842+96+0+2200HZ2842+96+0+22002025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479203355SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
00840479203362SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
06973541158100REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
06973541158117 REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
00620974004288BetterShieldSouthmedic IncorporatedHOY2025-12-19
00757770455409Bausch + LombBausch & Lomb IncorporatedHOY2025-08-22
00883205038227Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00883205038234Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00194613026080MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026165MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026172MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026189MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026219MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056322MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056346MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103637MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103644MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104269MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104276MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104337MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104979MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118723MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118730MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118907MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118914MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118921MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118938MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118945MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122546MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122553MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01