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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (6) Knife, ophthalmic (HNN) (4)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 00190660000905 Catalog Number : PR7412

Device Description : Bipolar pencil, 18 gauge, non-stick, curved tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660000936 Catalog Number : PR7410

Device Description : Bipolar pencil, 18 gauge, non-stick, straight tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660000943 Catalog Number : PR7420

Device Description : Bipolar pencil, 20 gauge, non-stick, straight tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660000974 Catalog Number : PR7426

Device Description : Bipolar pencil, 20/23 gauge, non-stick, blunt tapered tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660000998 Catalog Number : PR7425

Device Description : Bipolar pencil, 20/23 gauge, non-stick, sharp tapered tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660001018 Catalog Number : PR7423

Device Description : Bipolar pencil, 23 gauge, non-stick, straight tip, reusable

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ambler Surgical - 00190660001032 Catalog Number : 1054E

Device Description : Barraquer blade breaker and holder, 4 1/4'', heavy 12.0mm jaws, spring-clip end lock

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001056 Catalog Number : 1055E

Device Description : Castroviejo blade breaker and holder, 3 7/8'', squared jaws, round handle with slide lock

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001063 Catalog Number : 1015E

Device Description : Stainless steel breakable blades, non-sterile, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660001070 Catalog Number : 1017E

Device Description : Stainless steel breakable blades, non-sterile, box of 50

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

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