FDA.reportPublic FDA data

Sponge Bowl - 32 oz

Primary DI
10850007280038
Brand
Sponge Bowl - 32 oz
Company
NEWGEN SURGICAL, INC.
Model
NGS32SB-400NS
Catalog number
NGS32SB-400NS
Device description
Sponge Bowl, 32oz, non-sterile, EPP/sustainable Designed for use in medical procedures to hold fluids and medical supplies, this product features a biocompatible film coating for added safety. It is durable and strong, with easy-to-read graduations marked in milliliters and cubic centimeters for reference. The product is latex-free and can be sterilized using ethylene oxide (EO). Validated to hold a variety of prep solutions in addition to warm water, cold water, saline, and betadine for up to12 hours.
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBasin, Emesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007280038PrimaryGS10
00850007280031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000728003810850007280038
00850007280031008500072800318500072800310850007280031

Contacts#

Phone, Email table
PhoneEmail
415-457-1138sales@newgensurgical.com

Regulatory Flags#

DUNS number
037689420
Device count
400
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850007280182Needle counter, 30-60 count, double magnet, adhesive tabsNGSNC60MA-90NSNGSNC60MA-90NS2026-10-15
10850007280199Needle counter, 40-80 count, double foam, double magnet, adhesive tabsNGSNC80FFMMA-90NSNGSNC80FFMMA-90NS2026-10-15
10850007280205Needle counter, 100 count, foam block, double magnet, adhesive tabsNGSNC100FMMA-90NSNGSNC100FMMA-90NS2026-10-15
10850007280311Needle counter, 20 count, foam block, magnet, adhesive tabsNGSNC20MA-180NSNGSNC20MA-180NS2026-10-15
30864887000062Needle counter, 20 count, double magnet, adhesive tabsNGSNC20MA-360NSNGSNC20MA-360NS2026-10-15
30864887000079Needle counter, 30 count, double magnet, adhesive tabsNGSNC30MA-360NSNGSNC30MA-360NS2026-10-15
30864887000093Needle counter, 40 count, foam block, double magnet, adhesive tabsNGSNC40FMMA-90NSNGSNC40FMMA-90NS2026-10-15
00850007280345Two Compartment Tray CoatedNGS2CTC-250NSNGS2CTC-250NS2026-10-13
00850007280352One-Compartment Tray CoatedNGS1CTC-250NSNGS1CTC-250NS2026-10-13
10850007280250One-Compartment TrayNGS1CT-250NSNGS1CT-250NS2026-10-13
10850007280267Two Compartment TrayNGS2CT-250NSNGS2CT-250NS2026-10-13
00850007280284Ring Basin - 5500 ccNGS5500RBE-80NSNGS5500RBE-80NS2026-10-09
10850007280021Emesis Basin - 700 ccNGS700EB-250NSNGS700EB-250NS2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007280345Two Compartment Tray CoatedNEWGEN SURGICAL, INC.FNY2026-10-13
00850007280352One-Compartment Tray CoatedNEWGEN SURGICAL, INC.FNY2026-10-13
10850007280250One-Compartment TrayNEWGEN SURGICAL, INC.FNY2026-10-13
10850007280267Two Compartment TrayNEWGEN SURGICAL, INC.FNY2026-10-13
00850007280284Ring Basin - 5500 ccNEWGEN SURGICAL, INC.FNY2026-10-09
10850007280021Emesis Basin - 700 ccNEWGEN SURGICAL, INC.FNY2026-10-09
00724995252854V. MuellerSteris CorporationFNY2026-08-21
00724995252861V. MuellerSteris CorporationFNY2026-08-21
00724995252878V. MuellerSteris CorporationFNY2026-08-21
00724995252885V. MuellerSteris CorporationFNY2026-08-21
B382SD923302270Surgical DirectSurgical Direct, Inc.FNY2026-08-07
00850083275242Intrace USAPILOTIS TECH LLCFNY2026-07-03
00850083275259Intrace USAPILOTIS TECH LLCFNY2026-07-03
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
10198956251335CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251342CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251359CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
10198956138193CARDINAL HEALTHCardinal Health 200, LLCFNY2025-11-07
00661392001176LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012356LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20