FDA.report

Opthalmic Spatula

Primary DI
08903317019203
Brand
Opthalmic Spatula
Company
OVATION INTERNATIONAL
Model
OI-2290T-20G
Device description
MEMBRANE PICK, ANG. 120° 20G
Published
2022-01-21
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
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08903317019203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08903317019203089033170192038903317019203

GMDN Terms

TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
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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