FDA.report

Ophthalmic Knife

Primary DI
08903317020940
Brand
Ophthalmic Knife
Company
OVATION INTERNATIONAL
Model
OVS6401S
Device description
CRESCENT SHORT WIDTH STRAIGHT , SAFETY
Published
2022-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HNNKnife, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08903317020940PackageGS16In Commercial Distribution
08903317014512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08903317020940089033170209408903317020940
08903317014512089033170145128903317014512

GMDN Terms

TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Sterilization Methods

Method

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
true
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 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
08903317018183Opthalmic SpoonOI-3663T2022-02-04
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

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