FDA.reportPublic FDA data

HAI Spoon

Primary DI
00852194002120
Brand
HAI Spoon
Company
Hightech American Industrial Labs Inc
Model
1
Device description
Spoon, Surgical instrument for ophthalmic use
Published
2025-12-16
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNBSpoon, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNBSpoon, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852194002120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852194002120008521940021208521940021200852194002120

GMDN Terms#

Term, Definition table
TermDefinition
Lens spoonA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
961991916
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852194002007EB-3000xyz12025-12-25
00852194002021EB-2000xyz12025-12-25
00852194002137SL-500012025-12-18
00852194002151AB-610012025-12-18
00852194002090HAI Caliper12025-12-16
00852194002106HAI Trephine12025-12-16
00852194002113HAI Specula12025-12-16
00852194002144HAI Spatula12025-12-16
00852194002045HAI Scissisors12025-12-15
00852194002052HAI Knife12025-12-15
00852194002069HAI Cannula12025-12-15
00852194002076HAI Hook12025-12-15
00852194002083HAI Forceps12025-12-15
00852194002014HAI CL-1000xyz clinical specular microscope12025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784432526"Wooden Spoon, 3"""Dynarex CorporationHNB2026-04-27
G223140200700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2025-11-05
00194613063214MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2025-08-01
04058935012724Wells Enucleation SpoonBausch & Lomb GmbHHNB2025-07-10
04058935012731Bunge Enucleation SpoonBausch & Lomb GmbHHNB2025-07-10
04058935012748Bunge Enucleation SpoonBausch & Lomb GmbHHNB2025-07-10
G22314020090Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2025-06-04
G223140200800Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2025-01-14
00757770410163Bausch + LombBausch & Lomb IncorporatedHNB2024-11-21
00757770427017Bausch + LombBausch & Lomb IncorporatedHNB2024-11-21
00757770427963Bausch + LombBausch & Lomb IncorporatedHNB2024-11-21
00194613004903MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00194613004927MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00194613041571MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00194613046828MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00194613063122MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00194613063542MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
00840319757277Hayden MedicalHayden Medical, Inc.HNB2024-05-17
00840319757284Hayden MedicalHayden Medical, Inc.HNB2024-05-17
G2231137200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2023-08-30
G2231137400Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2023-08-30
G2231137420Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2023-08-30
G22312207190Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2023-06-08
00841668130261PEREZ-SILGUERO LOOP DEVICEKATENA PRODUCTS, INC.HNB2022-12-14
00841668129388GROOVED DONOR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
00841668129876LEWIS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129920MORRISON LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129975NEW ORLEANS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130018KANSAS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130025WILDER LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07