FDA.report

Disposable Backflush instrument, with extended silicone tip and active aspiratio

Primary DI
18717872003990
Brand
Disposable Backflush instrument, with extended silicone tip and active aspiratio
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1281.TDM
Catalog number
1281.TDM
Device description
Disposable Backflush instrument, with extended silicone tip and active aspiration.(20 gauge / 0.9 mm)
Published
2021-02-02
Public version status
Update
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
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717872003993PrimaryGS10
18717872003990Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717872003993087178720039938717872003993
1871787200399018717872003990

GMDN Terms

TermDefinition
Vitrectomy fluid/gas handling handpiece/cannulaA sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
407522184
Device count
5
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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