AMBLER SURGICAL CORP.

Address:730 Springdale Drive,EXTON,PA,19341,US

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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

Caliper, ophthalmic (HOE) (7) GAUGE, MEASURING (JYJ) (1) Knife, ophthalmic (HNN) (1) TAPE, MEASURING, RULERS AND CALIPERS (FTY) (1)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 00190660001087 Catalog Number : 1052E

Device Description : Swiss blade breaker and holder, 4 3/4'' conical 13.0mm jaws

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001643 Catalog Number : 14-080

Device Description : Aluminum caliper, 8 1/2'', measurements in inches and millimeters up to 6''

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001650 Catalog Number : 14-100

Device Description : Austin strut caliper and measuring gauge, 6 1/4'', straight shaft, prongs at 3.5 Austin strut caliper and measuring gauge, 6 1/4'', straight shaft, prongs at 3.5mm and 4.5mm, groove at 4.0mm, round handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : JYJ

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001667 Catalog Number : 2103E

Device Description : Braunstein fixed caliper, 2 3/4'', aphakic: 2.0mm, phakic: 2.5mm

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001674 Catalog Number : 2101E

Device Description : Braunstein fixed caliper, 2 3/4'', aphakic: 3.0mm, phakic: 3.5mm

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001681 Catalog Number : 2101T

Device Description : Braunstein fixed caliper, 2 3/4'', aphakic: 3.0mm, phakic: 3.5mm, titanium

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001698 Catalog Number : 2100E

Device Description : Braunstein fixed caliper, 2 3/4'', aphakic: 3.5mm, phakic: 4.0mm

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001711 Catalog Number : 2100T

Device Description : Braunstein fixed caliper, 2 3/4'', aphakic: 3.5mm, phakic: 4.0mm, titanium

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001728 Catalog Number : 14-113

Device Description : Castroviejo caliper, 3 1/2'', angled tips, measures from 0-40mm in 1.0mm increme Castroviejo caliper, 3 1/2'', angled tips, measures from 0-40mm in 1.0mm increments, adjustable thumb-screw tension

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001735 Catalog Number : 1145E

Device Description : Castroviejo caliper, 3 1/2'', curved tips, measures from 0-20mm in 1.0mm increme Castroviejo caliper, 3 1/2'', curved tips, measures from 0-20mm in 1.0mm increments, adjustable thumb-screw tension

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

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