FDA.reportPublic FDA data

andorate® Eye Cornea Protectors

Primary DI
14897106953650
Brand
andorate® Eye Cornea Protectors
Company
GA Health Company Limited
Model
GAR001-NP
Published
2021-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HMPPad, Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMPPad, EyeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24897106953657PackageGS110000In Commercial Distribution
14897106953650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2489710695365724897106953657
1489710695365014897106953650

GMDN Terms#

Term, Definition table
TermDefinition
Eye patch, single-useA device intended to be used to close/cover one or both eyes to protect the eye after a procedure and/or as part of an ophthalmic therapeutic intervention (e.g., after cataract surgery or for the treatment of amblyopia). It is made of a synthetic or biological material. This is a single-use device.

Regulatory Flags#

DUNS number
686908512
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897106956081andorate® ThomasTrap ™ Polyp Trap 2.0GAR1040402026-03-18
04897106958566andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010472026-03-18
04897106958573andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010482026-03-18
04897106958597andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010672026-03-18
04897106958603andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010682026-03-18
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
04897106958016andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
04897106958023andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
04897106957910andorate® 4-piece valve kit1010662026-03-12
04897106958559andorate® 4-piece valve kit1010462026-03-12
04897106958580andorate® 3-piece Valve Kit1010652026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950396345510Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345527Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-02-26
06950396345435Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
06950396345459Medi GradeHenan Chaoya Medical Equipment Co., Ltd.HMP2026-01-28
00810124532116Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532123Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532130Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532147Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
00810124532109Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2025-09-03
10653160388708MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
00653160388701MEDLINEMEDLINE INDUSTRIES, INC.HMP2025-07-14
08681756010349PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010356PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756010028PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08681756012916PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
08682952413262PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIHMP2025-06-30
00690521023932Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521023949Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
00690521025165Panda Adhesive Eye ProtectorsBatrik Medical Manufacturing IncHMP2024-12-20
16974567748075RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
16974567748082RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748085RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
06974567748078RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HMP2024-08-12
00840117334762"Eyepad - 18""x 36"" "Dynarex CorporationHMP2024-03-25
00840117334755Eyepad - 18"x 36" DYNAREX CORPORATIONHMP2024-03-25
00810077219904Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219911Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219928Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219935Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04
00810077219942Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyHMP2023-11-04