FDA.reportPublic FDA data

Pro-Paks

Primary DI
10810003224412
Brand
Pro-Paks
Company
MICROSPECIALITIES, INC.
Model
MK-100
Device description
Premium PVA Spear. Our effective synthetic PVA sponges and fluid management items are highly absorbent allowing aqueous solutions to be wicked up quickly. 15 per box with 10 pieces each.
Published
2022-12-11
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810003224412PrimaryGS10
00810003224415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000322441210810003224412
00810003224415008100032244158100032244150810003224415

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.

Contacts#

Phone, Email table
PhoneEmail
203-874-1832customerservice@pro-paks.com

Regulatory Flags#

DUNS number
013469890
Device count
10
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810003224757NAMK8510LSKMK8510LSK2026-04-29
10810003224764NAMK8511CB2026-04-29
10810003224771NA3001352026-04-29
10810003224788NA3001602026-04-29
10810003224795NA300202026-04-29
10810003224801NAMK85072026-04-29
10810003224818NAMK85082026-04-29
10810003223545Comfortear™24-200824-20082019-01-03
10810003223552Comfortear™24-200724-20072019-01-03
10810003223569Comfortear™24-200624-20062019-01-03
10810003223576Comfortear™24-200524-20052019-01-03
10810003223583Comfortear™24-200424-20042019-01-03
10810003223590Comfortear™32-200832-20082019-01-03
10810003223606Comfortear™32-200732-20072019-01-03
10810003223613Comfortear™32-200632-20062019-01-03
10810003223620Comfortear™32-200532-20052019-01-03
10810003223637Comfortear™32-200432-20042019-01-03
10810003223644Comfortear™60-601060-60102019-01-03
10810003224443Pro-Paks1002PL1002PL2023-09-02
10810003224450Pro-Paks2002PL2002PL2023-09-02

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