FDA.reportPublic FDA data

Oph.Spatula

Primary DI
00841668120255
Brand
Oph.Spatula
Company
KATENA PRODUCTS, INC.
Model
08-14202R
Catalog number
08-14202R
Device description
McIntyre II Cutting Board - RH Dominant
Published
2022-11-16
Public version status
Update
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
00841668120255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668120255008416681202558416681202550841668120255

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

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
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