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

RING, OPHTHALMIC (FLIERINGA) (HNH) (6) INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (2) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (1) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 00190660000240 Catalog Number : 2087E

Device Description : Camellin style LASIK alcohol well, 4'', 7.5mm diameter, 3.5mm high, flat handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000257 Catalog Number : 2088E

Device Description : Camellin style LASIK alcohol well, 4'', 8.0mm diameter, 3.5mm high, flat handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000264 Catalog Number : 2090E

Device Description : Camellin style LASIK alcohol well, 4'', 8.5mm diameter, 3.5mm high, flat handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000271 Catalog Number : 2091E

Device Description : Camellin style LASIK alcohol well, 4'', 9.0mm diameter, 3.5mm high, flat handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000288 Catalog Number : 2092E

Device Description : Camellin style LASIK alcohol well, 4'', 9.5mm diameter, 3.5mm high, flat handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000301 Catalog Number : 8898E

Device Description : Hyver PRK/LASEK alcohol well, 3 3/4'', 7.5mm x 8.5mm oval diameter, 3.0mm ring h Hyver PRK/LASEK alcohol well, 3 3/4'', 7.5mm x 8.5mm oval diameter, 3.0mm ring height, semi-sharp bottom edge, used to limit the extent of epithelium removal for mixed astigmatism treatment, round handle

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000486 Catalog Number : 43-165

Device Description : Lemmon sternal approximator, 7'', adult size

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000493 Catalog Number : 43-170

Device Description : Sternal approximator

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000509 Catalog Number : 43-160

Device Description : Tendon approximator, 1 5/8'', 23.0mm spread

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000851 Catalog Number : BC-106

Device Description : Bipolar cord, 12', 45° connector, fits O.M.S type connector, package of 1

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

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