FDA.reportPublic FDA data

SOFT CELL® PVA Foam Surgical Spears

Primary DI
10845819000165
Brand
SOFT CELL® PVA Foam Surgical Spears
Company
OASIS MEDICAL, INC.
Model
0525, 0525-A
Catalog number
0525
Device description
SOFT CELL® PVA Foam Surgical Spears
Published
2018-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOZSponge, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOZSponge, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082460000CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.2008-12-15HOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845819000162PackageGS115In Commercial Distribution
30845819000169PackageGS110In Commercial Distribution
10845819000165PrimaryGS10
00845819000168Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084581900016220845819000162
3084581900016930845819000169
1084581900016510845819000165
00845819000168008458190001688458190001680845819000168

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pore Size250Micrometer

Contacts#

Phone, Email table
PhoneEmail
909-305-5400customerservice@oasismedical.com

Regulatory Flags#

DUNS number
194121018
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
10845819005474SOFT PLUG® Extended Duration Plugs 5032023-06-30
10845819005498SOFT PLUG® Extended Duration Plugs 5052023-06-30
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
00845819003138Surgeon's Choice CardSCK-2012, B-SCK-20122025-10-02
00845819006375Surgeon's Choice CardSCK 2005, B-SCK 20052023-06-30
00845819020111Surgeon's Choice CardSCK 20112024-11-07
10845819020118Surgeon's Choice CardB-SCK 20112024-11-07
00845819002919Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
00845819002926Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
10845819002916Premier Edge® Microsurgical KnivesPE3128-SL, B-PE3128-SL2023-12-31
10845819002923Premier Edge® Microsurgical KnivesPE3818, B-PE38182023-12-31
00845819002988Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002971Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
10845819002985Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
00845819002322Premier Edge® Microsurgical KnivesPE4827-TL, B-PE4827-TL2023-04-30
00845819000267SOFT PLUG® Extended Duration Plugs 6400V2023-07-31
10845819000219SOFT PLUG® Extended Duration Plugs 6402, 6402-A2023-07-31
10845819000097SOFT PLUG® Silicone Punctum Plug6610-EP2023-06-30
10845819000110SOFT PLUG® Silicone Punctum Plug6611-EP2023-06-30

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