FDA.reportPublic FDA data

Ultracell

Primary DI
30886158012161
Brand
Ultracell
Company
Beaver-Visitec International, Inc.
Model
NS40430
Device description
Wick with 80cc Collection Bag
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
30886158012161PrimaryGS10
00886158012160Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615801216130886158012161
00886158012160008861580121608861580121600886158012160

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tissue/fluid collection bag, non-sterileA non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com

Regulatory Flags#

DUNS number
001406024
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27
30886158002650Visitec®5817085817082024-06-06
30886158010358Visitec000860100086012024-06-06
00886158002321Visiwipe5810475810472025-09-10
00886158106586BVIELP19CU5ELP19CU52025-09-10

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