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) (1) KNIFE, EAR (JYO) (1)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 10190660200388 Catalog Number : 7300H

Device Description : Myringotomy sickle knife, straight, full handle knife, flat stock, packaged indi Myringotomy sickle knife, straight, full handle knife, flat stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : JYO

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660211216 Catalog Number : PD7227

Device Description : Bipolar pencil, 27 gauge, non-stick, straight tip, packaged individually sterile Bipolar pencil, 27 gauge, non-stick, straight tip, packaged individually sterile, disposable, box of 5

Device Class : 2

Duns Number: 015272206

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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