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

TONSILLECTOME (KCA) (6) ADENOTOME (KBH) (4)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 00190660000042 Catalog Number : 10-101

Device Description : Daniels tonsillectome replacement blade, size #1, 18.0mm wide

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000059 Catalog Number : 10-103

Device Description : Daniels tonsillectome replacement blade, size #2, 22.0mm wide

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000066 Catalog Number : 10-105

Device Description : Daniels tonsillectome replacement blade, size #3, 26.0mm wide

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000073 Catalog Number : 10-100

Device Description : Daniels tonsillectome, size #1, 18.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000080 Catalog Number : 10-102

Device Description : Daniels tonsillectome, size #2, 22.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000097 Catalog Number : 10-104

Device Description : Daniels tonsillectome, size #3, 26.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KCA

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000103 Catalog Number : 10-124

Device Description : LaForce adenotome, large size, 18.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KBH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000110 Catalog Number : 10-123

Device Description : LaForce adenotome, medium size, 16.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KBH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000127 Catalog Number : 10-122

Device Description : LaForce adenotome, small size, 12.0mm wide blade

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KBH

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 00190660000134 Catalog Number : 10-161

Device Description : LaForce/Shambaugh replacement adenotome blade, child size, 11.0mm wide

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : KBH

Prescription Use : Yes

Device Count : 1

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