FDA.report

Opthalmic Spoon

Primary DI
08903317018183
Brand
Opthalmic Spoon
Company
OVATION INTERNATIONAL
Model
OI-3663T
Device description
MULE EVISCERATION SPOON SMALL
Published
2022-02-04
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

Related Records

Product Codes

CodeName
HNBSpoon, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNBSpoon, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08903317018183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08903317018183089033170181838903317018183

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
879324241
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08903317017452Opthalmic SpoonOI-3152T2022-02-04
08903317017469Opthalmic SpoonOI-3153T2022-02-04
08903317018138Opthalmic SpoonOI-3658T2022-02-04
08903317018145Opthalmic SpoonOI-3659T2022-02-04
08903317018152Opthalmic SpoonOI-3660T2022-02-04
08903317018169Opthalmic SpoonOI-3661T2022-02-04
08903317018176Opthalmic SpoonOI-3662T2022-02-04
08903317018190Opthalmic SpoonOI-3664T2022-02-04
08903317018206Opthalmic SpoonOI-3665T2022-02-04
08903317031076Opthalmic SpoonOI-3151S2022-02-04
08903317031083Opthalmic SpoonOI-3152S2022-02-04
08903317031090Opthalmic SpoonOI-3153S2022-02-04
08903317031366Opthalmic SpoonOI-3658S2022-02-04
08903317031373Opthalmic SpoonOI-3659S2022-02-04
08903317031380Opthalmic SpoonOI-3660S2022-02-04
08903317031397Opthalmic SpoonOI-3661S2022-02-04
08903317031403Opthalmic SpoonOI-3662S2022-02-04
08903317031410Opthalmic SpoonOI-3663S2022-02-04
08903317031427Opthalmic SpoonOI-3664S2022-02-04
08903317031434Opthalmic SpoonOI-3665S2022-02-04

Other Devices Sharing Product Codes

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