FDA.reportPublic FDA data

Eighteeth

Primary DI
06941877840389
Brand
Eighteeth
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
ibT5035E(5X350-Elite-TR90-Wide-SL-FDA)
Catalog number
5088219
Device description
This device is a manual instrument and used in general surgery. It is intended for magnifying the surgical area for the surgeon during the operation. It is widely used in dentistry, ENT and other general surgery.
Published
2026-11-03
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

Product Codes#

Code, Name table
CodeName
FSPLoupe, Diagnostic/Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941877840389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941877840389069418778403896941877840389

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941877840372EighteethibT5035E(5X350-Elite-TR90-Wide-BK-FDA)50882182026-11-03
06941877840396EighteethibT5040E(5X400-Elite-TR90-Wide-BK-FDA)50882202026-11-03
06941877840402EighteethibT5040E(5X400-Elite-TR90-Wide-SL-FDA)50882212026-11-03
06941877840419EighteethibT5045E(5X450-Elite-TR90-Wide-BK-FDA)50882222026-11-03
06941877840426EighteethibT5045E(5X450-Elite-TR90-Wide-SL-FDA)50882232026-11-03
06941877840433EighteethibT5050E(5X500-Elite-TR90-Wide-BK-FDA)50882242026-11-03
06941877840440EighteethibT5050E(5X500-Elite-TR90-Wide-SL-FDA)50882252026-11-03
06941877840457EighteethibT5035E(5X350-Elite-TR90-Narrow-BK-FDA)50882262026-11-03
06941877840464EighteethibT5035E(5X350-Elite-TR90-Narrow-SL-FDA)50882272026-11-03
06941877840471EighteethibT5040E(5X400-Elite-TR90-Narrow-BK-FDA)50882282026-11-03
06941877840488EighteethibT5040E(5X400-Elite-TR90-Narrow-SL-FDA)50882292026-11-04
06941877840495EighteethibT5045E(5X450-Elite-TR90-Narrow-BK-FDA)50882302026-11-04
06941877840501EighteethibT5045E(5X450-Elite-TR90-Narrow-SL-FDA)50882312026-11-04
06941877840518EighteethibT5050E(5X500-Elite-TR90-Narrow-BK-FDA)50882322026-11-04
06941877840525EighteethibT5050E(5X500-Elite-TR90-Narrow-SL-FDA)50882332026-11-04
06941877830519KulzerKulzer Translux Cure65800092026-10-19
06941877830557EighteethHyperLight-M70803272026-10-08
06941877830090EighteethE-FLEX REC-20351831062026-06-09
06941877830106EighteethE-FLEX REC-22051831232026-06-09
06941877830113EighteethE-FLEX REC-22151831242026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877840488EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-04
06941877840495EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-04
06941877840501EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-04
06941877840518EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-04
06941877840525EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-04
06941877840372EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840396EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840402EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840419EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840426EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840433EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840440EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840457EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840464EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877840471EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-11-03
06941877825287EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825294EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825300EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825317EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825324EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825096EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825102EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825119EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825126EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825133EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825140EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825157EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825164EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825171EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825188EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30