FDA.reportPublic FDA data

Pro-ophta@

Primary DI
04021447165158
Brand
Pro-ophta@
Company
Lohmann & Rauscher International GmbH & Co KG
Model
Ocular Sticks
Catalog number
16515
Published
2016-10-17
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
HOZSponge, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOZSponge, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04021447009735PackageGS150In Commercial Distribution
04021447165158PrimaryGS10
04021447088693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04021447009735040214470097354021447009735
04021447165158040214471651584021447165158
04021447088693040214470886934021447088693

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spongeA device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from light
Special Storage Condition, Specify00keep dry

Regulatory Flags#

DUNS number
315505235
Device count
500
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04021447537771DebrisoftPad 10x10cm312222022-11-17
04056649025665DebrisoftLolly332242023-06-07
04056649070344DebrisoftPad 10x10cm343212022-11-17
04056649070429DebrisoftPad 13x20cm343232022-11-17
04068225259449DebrisoftDuo 10x10cm1599902024-10-16
04068225259463DebrisoftDuo 13x20cm1599912024-10-16
04068225269608DebrisoftDuo 10x10cm1599922024-10-16
04068225274879DebrisoftDuo 10x10cm312222024-10-16
04021447206028VaricexZinc Paste Bandage206022022-11-17
04021447206325VaricexZinc Paste Bandage206322022-11-17
04068225066924SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066955SuprasorbF Protect 5 x 7 cm1624612024-11-15
04068225066986SuprasorbF Protect 10 cm x 12 cm1624622024-11-15
04068225067013SuprasorbF Protect 10 cm x 12 cm1624632024-11-15
04068225067044SuprasorbF Protect 10 cm x 25 cm1624642024-11-15
04068225067075SuprasorbF Protect 15 cm x 20 cm1624652024-11-15
04068225067105SuprasorbF Protect 20 x 30 cm1624662024-11-15
04068225066931SuprasorbF Protect 5 x 7 cm1624602024-11-15
04068225066962SuprasorbF Protect 5 x 7 cm1624612024-11-15
04068225066993SuprasorbF Protect 10 cm x 12 cm1624622024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840516145747Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
00840516145761Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
10385640090008WalcottSummit Medical, Inc.HOZ2026-02-03
10385640090015WalcottSummit Medical, Inc.HOZ2026-02-03
30385640090019WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090005WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090012WalcottSummit Medical, Inc.HOZ2026-02-03
40385640090016WalcottSummit Medical, Inc.HOZ2026-02-03
04260306710522Sugi sterile, sample, ophthalmologyQuestAlpha GmbH & Co. KGHOZ2025-08-15
00194613056841MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056872MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056896MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056919MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056926MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613100070MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118778MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118785MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118792MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118808MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118983MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118990MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119003MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119010MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119027MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056889MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-03-21
00194613018276MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
00194613060749MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613018273MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613060746MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
04260306710478SugiQuestAlpha GmbH & Co. KGHOZ2024-07-31