FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319757284
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
E3-4244
Catalog number
E3-4244
Device description
Camellin Style LASEK 8.5mm Alcohol Well, flat handle, stainless steel
Published
2024-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00840319757284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319757284008403197572848403197572840840319757284

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6612967200tom@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12
00840319758892Hayden MedicalE7-0226E7-02262026-03-31
00840319758922Hayden MedicalE7-2234E7-22342026-03-31
00840319758939Hayden Medical210-179210-1792026-03-31
00840319758885Hayden MedicalE5-6271E5-62712026-03-27
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319737798Hayden Medical105-432105-4322023-03-17
00840319733134Hayden Medical105-432-10105-432-102022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784432526"Wooden Spoon, 3"""Dynarex CorporationHNB2026-04-27
00852194002120HAI SpoonHightech American Industrial Labs IncHNB2025-12-16
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
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