FDA.reportPublic FDA data

Oph.Spoon

Primary DI
00841668119976
Brand
Oph.Spoon
Company
KATENA PRODUCTS, INC.
Model
08-13102
Catalog number
08-13102
Device description
Bunge Evisceration Spoon, Large 11mm cup
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841668119976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668119976008416681199768416681199760841668119976

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth11Millimeter

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668145906BLINK60-127360-12732026-03-23
00841668145913BLINK60-128060-12802026-03-23
00841668145920BLINK60-128160-12812026-03-23
00841668145937BLINK60-128460-12842026-03-23
00841668145944BLINK60-128560-12852026-03-23
00841668145951BLINK60-159260-15922026-03-23
00841668145968BLINK60-159960-15992026-03-23
00841668145982BLINK60-161060-16102026-03-23
00841668145999BLINK60-161760-16172026-03-23
00841668146002BLINK60-161860-16182026-03-23
00841668146019BLINK60-163060-16302026-03-23
00841668146040BLINK60-163960-16392026-03-23
00841668146057BLINK60-164260-16422026-03-23
00841668146071BLINK60-500460-50042026-03-23
00841668146088BLINK60-500660-50062026-03-23
00841668146095BLINK60-500860-50082026-03-23
00841668146101BLINK60-500960-50092026-03-23
00841668146118BLINK60-502560-50252026-03-23
00841668146125BLINK60-502660-50262026-03-23
00841668146132BLINK60-503060-50302026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852194002120HAI SpoonHightech American Industrial Labs IncHNB2025-12-16
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
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
00841668130063BARRAQUER LENTICULAR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
00841668130070CULLER LENS SPOONKATENA PRODUCTS, INC.HNB2022-12-07