Optalmed, LLC

Optalmed, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Clip, Iris Retractor (HOC) (10)

Premarket Exempt

Yes

Clear

N/A - 00850003089003 Catalog Number : 7001

Device Description : Disposable Iris Retractors, 1 set of 5 retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089010 Catalog Number : 7002

Device Description : Disposable Iris Retractors, 6 sets of 5 retractors

Device Class :

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089034 Catalog Number : 7003

Device Description : Reusable Iris Retractors, 1 set of 6 retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 6

N/A - 00850003089041 Catalog Number : 7004

Device Description : Disposable Flat Iris Retractors, 1 set of 5 retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089058 Catalog Number : 7013

Device Description : Disposable Flat Iris Retractors, 6 sets of 5 retractors

Device Class :

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089072 Catalog Number : Rx5213

Device Description : Disposable Flat Iris Retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089089 Catalog Number : Rx5067B-5

Device Description : Disposable Iris Retractors

Device Class :

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

N/A - 00850003089171 Catalog Number : Rx5127

Device Description : Reusable Iris Retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 6

N/A - 00850003089188 Catalog Number : 30-254

Device Description : Reusable Iris Retractors

Device Class : 1

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 6

N/A - 00850003089201 Catalog Number : 30-134-6

Device Description : Disposable Iris Retractors

Device Class :

Duns Number: 037077801

Premarket Exempt : Yes

Product Code : HOC

Prescription Use : Yes

Device Count : 5

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