FCI S A S FCI 20 22

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- Catalog Number : S2.3422u

Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

- Catalog Number : S2.3522u

Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

- Catalog Number : S2.3632u

Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

- Catalog Number : S2.3642u

Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

- Catalog Number : S2.3652u

Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

- Catalog Number : S2.4002u

Device Description : A sterile device inserted into a punctal opening to prevent tear outflow in dry A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : LZU

Prescription Use : Yes

Device Count : 2

Device Description : An ophthalmic device that is implanted subcutaneously within the upper eyelid to An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

Device Class : 1

Duns Number: 763408366

Premarket Exempt : Yes

Product Code : HJZ

Prescription Use : Yes

Device Count : 3

Device Description : An ophthalmic device that is implanted subcutaneously within the upper eyelid to An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

Device Class : 1

Duns Number: 763408366

Premarket Exempt : Yes

Product Code : HJZ

Prescription Use : Yes

Device Count : 1

Device Description : An ophthalmic device that is implanted subcutaneously within the upper eyelid to An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

Device Class : 1

Duns Number: 763408366

Premarket Exempt : Yes

Product Code : HJZ

Prescription Use : Yes

Device Count : 1

Device Description : A sterile, non-bioabsorbable device intended to be implanted for intrascleral an A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

Device Class :

Duns Number: 763408366

Premarket Exempt : No

Product Code : HQX

Prescription Use : Yes

Device Count : 5