FDA.reportPublic FDA data

Clip-on Loupe 5 Diopter (#715)

Primary DI
D2488702100
Brand
Clip-on Loupe 5 Diopter (#715)
Company
HAGER WORLDWIDE, INC.
Model
87021
Device description
Clip-on Loupe 5 Diopter (#715) Eyewear
Published
2023-05-15
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
false

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
D2488702100PrimaryHIBCC0

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags#

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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D2483552540BurButler ( 10 Hole Pink Base w/Lid)3552542024-07-15
D2483552560BurButler ( 10 Hole Blue Base w/Lid)3552562024-07-15
D2483552600BurButler ( 25 Hole Pink Base w/Lid)3552602024-07-15
D2483552620BurButler ( 25 Hole Blue Base w/Lid)3552622024-07-15
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D2481550180Reso-Pac Hydrophilic Periodontal Dressing1550182016-09-22
D2481550190Reso-Pac Hydrophilic Periodontal Dressing1550192016-09-22
D2483553190Plast Frame3553192024-04-16
D248222300SafeDispense - Silver222302024-04-12
D248222310Mini SafeDispense222312024-04-12
D248222360SafeDispense - White222362024-04-12

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
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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