FDA.reportPublic FDA data

One-Compartment Tray

Primary DI
10850007280250
Brand
One-Compartment Tray
Company
NEWGEN SURGICAL, INC.
Model
NGS1CT-250NS
Catalog number
NGS1CT-250NS
Device description
The One-Compartment Tray is designed for use in medical procedures to conveniently hold fluids and medical supplies. It features a biocompatible film coating and a durable, strong construction to support reliable performance. The tray is a sustainable, plant-based alternative to existing plastic general-purpose bowl products currently on the market. The tray is EO sterilizable, latex-free, and intended for single use only, making it suitable for a variety of medical applications. Validated to hold a variety of prep solutions in addition to warm water, cold water, saline, and betadine for up to12 hours.
Published
2026-10-13
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
10850007280250PrimaryGS10
00850007280253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000728025010850007280250
00850007280253008500072802538500072802530850007280253

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, single-useA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
037689420
Device count
250
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
00850007280345Two Compartment Tray CoatedNGS2CTC-250NSNGS2CTC-250NS2026-10-13
00850007280352One-Compartment Tray CoatedNGS1CTC-250NSNGS1CTC-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
10850007280038Sponge Bowl - 32 ozNGS32SB-400NSNGS32SB-400NS2026-10-09

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
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
10850007280038Sponge Bowl - 32 ozNEWGEN 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