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

Knife, ophthalmic (HNN) (10)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 10190660199941 Catalog Number : 942268

Device Description : Crescent 2.25mm angled double-bevel symmetry blade, full handle knife, round sto Crescent 2.25mm angled double-bevel symmetry blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199958 Catalog Number : 960012

Device Description : Crescent 3.0mm angled bevel up NexGen blade, screw-in collet, round stock, packa Crescent 3.0mm angled bevel up NexGen blade, screw-in collet, round stock, packaged individually, sterile, disposable, box of 6 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * *

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199965 Catalog Number : 960021

Device Description : Crescent 2.0mm straight NexGen blade, full handle knife, round stock, packaged i Crescent 2.0mm straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199972 Catalog Number : 960022

Device Description : Crescent 2.0mm angled bevel up NexGen blade, full handle knife, round stock, pac Crescent 2.0mm angled bevel up NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199989 Catalog Number : 961161

Device Description : MICS Slit knife, 1.1mm wide, angled blade, full handle knife, round stock, packa MICS Slit knife, 1.1mm wide, angled blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199996 Catalog Number : 961501

Device Description : 15 degree stab knife, straight NexGen blade, full handle knife, round stock, pac 15 degree stab knife, straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200005 Catalog Number : 961502

Device Description : 15 degree stab blade, straight NexGen blade, screw-in collet, round stock, packa 15 degree stab blade, straight NexGen blade, screw-in collet, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200012 Catalog Number : 961520

Device Description : MICS Slit knife, 1.5mm x 2.0mm wide, angled trapezoid blade, full handle knife, MICS Slit knife, 1.5mm x 2.0mm wide, angled trapezoid blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * *

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200029 Catalog Number : 962061

Device Description : MICS Slit knife, 2.0mm wide, angled blade, full handle knife, round stock, packa MICS Slit knife, 2.0mm wide, angled blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660200036 Catalog Number : 962201

Device Description : 22.5 degree stab knife, straight NexGen blade, full handle knife, round stock, p 22.5 degree stab knife, straight NexGen blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : Yes

Device Count : 1

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