FDA.report

Eighteeth

Primary DI
06975132954191
Brand
Eighteeth
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
ibG3540S
Published
2024-03-25
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

Related Records

Product Codes

CodeName
FSPLoupe, Diagnostic/Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975132954191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975132954191069751329541916975132954191

GMDN Terms

TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
560366787
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
06941877827809ZarcZ-Evo60802792026-01-05
06941877827816ZarcZ-Down63800382026-01-05
06941877827823ZarcZ-Up63801252026-01-05
06941877819231EighteethLux-SFT50809012025-04-17
06941877819248EighteethWireless Z50809022025-04-17
06941877821456EighteethAcuvision X53800092025-04-17
06941877822248EighteethWireless Z+5080909 2025-04-17
06941877815196EighteethNanoPix1.569800982025-01-21
06941877803193EighteethHyperLight2024-03-26
06941877802967EighteethibG3050S2024-03-25
06941877802974EighteethibG3050S2024-03-25
06941877802981EighteethibG3050S2024-03-25
06941877802998EighteethibG3050S2024-03-25
06941877803001EighteethibG3050S2024-03-25
06941877803018EighteethibG3050D2024-03-25
06941877803025EighteethibG3050D2024-03-25
06941877803032EighteethibG3050D2024-03-25
06941877803049EighteethibG3050D2024-03-25
06941877803056EighteethibG3050D2024-03-25
06941877803063EighteethibG3535S2024-03-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850036373377Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373384Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373391Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373438Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373445Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373452Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00723896025321TTL Easy Size 2.5X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025338TTL Easy Size 3.0X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025505TTL Easy Size 2.5X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896025512TTL Easy Size 3.0X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896030097TTL Easy Size 2.5X Loupes BlackPRACTICON, INC.FSP2026-01-07
00723896030103TTL Easy Size 3.0X Loupes BlackPRACTICON, INC.FSP2026-01-07
00850036373902ErgoZoom™ PlanoMETREX RESEARCH, LLCFSP2025-07-21
00850036373919ErgoZoom™ RxMETREX RESEARCH, LLCFSP2025-07-21
00850036373926ErgoZoom™ Plano - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00850036373933ErgoZoom™ Rx - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00810186670054Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670061Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670078Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670085Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670092Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670108Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670115Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670122Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00615375010129Universal Flip - PlanoMETREX RESEARCH, LLCFSP2025-04-30
00615375010136Universal Flip - RxMETREX RESEARCH, LLCFSP2025-04-30
00615375014493Dragonfly™ - Headlight only - PlanoMETREX RESEARCH, LLCFSP2025-04-30