FDA.reportPublic FDA data

COTISEN

Primary DI
06954454001110
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
FF05
Device description
Safety Glasses Face Shield with Frame is used to protect the eyes or face from liquid or droplets or Strong light during medical examinations and treatments.
Published
2026-11-02
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454001110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454001110069544540011106954454001110

Contacts#

Phone, Email table
PhoneEmail
+1443-221-3031usa@medpath.pro

Regulatory Flags#

DUNS number
529444628
Device count
1
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
false
Expiration date on label
true
Donation ID number
true
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
06954454000496COTISENTB012026-11-02
06954454000502COTISENSG012026-11-02
06954454000519COTISENSG032026-11-02
06954454000526COTISENFF012026-11-02
06954454000878COTISENMP032026-11-02
06954454001004COTISENIT062026-11-02
06954454001011COTISENBT2026-11-02
06954454001028COTISENIT052026-11-02
06954454001035COTISENIT072026-11-02
06954454001059COTISENBP012026-11-02
06954454001066COTISENBP022026-11-02
06954454001073COTISENBP032026-11-02
06954454001080COTISENBP042026-11-02
06954454001127COTISENDE012026-11-02
06954454001134COTISENYK032026-11-02
06954454002056COTISENFF042026-11-02
06954454002063COTISENSG082026-11-02
06954454002087COTISENFF01022026-11-02
06954454002124COTISENFF05022026-11-02
06954454002155COTISENMP032026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000502COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454000519COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454000526COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454001127COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454001134COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002056COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002063COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002087COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002124COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002292COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454002452COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454004173COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454004883COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454016176COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
06954454016183COTISENHuanghua Promisee Dental Co., Ltd.KPY2026-11-02
00816611026663AngioSystems SorbXANGIOSYSTEMS, INCORPORATEDKPY2026-09-29
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08