AMBLER SURGICAL CORP.

Address:730 Springdale Drive,EXTON,PA,19341,US

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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

Cannula, ophthalmic (HMX) (8) Probe, lachrymal (HNL) (2)

Premarket Exempt

No Yes

Clear

Ambler Surgical - 10190660199507 Catalog Number : 205248

Device Description : Lane LASIK irrigating cannula, 25 gauge x 7/8'', extended spatulated tip, 2 side Lane LASIK irrigating cannula, 25 gauge x 7/8'', extended spatulated tip, 2 side ports, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199514 Catalog Number : 205250

Device Description : Lindstrom LASIK irrigating cannula, 25 gauge x 7/8'', vaulted, 6 ports, packaged Lindstrom LASIK irrigating cannula, 25 gauge x 7/8'', vaulted, 6 ports, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199521 Catalog Number : 205251

Device Description : Modified Slade LASIK irrigating cannula, 25 gauge x 7/8'', vaulted, spatulated t Modified Slade LASIK irrigating cannula, 25 gauge x 7/8'', vaulted, spatulated tip, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199538 Catalog Number : 205252

Device Description : Hersch LASIK irrigating cannula, 23 gauge x 7/8'', spatulated tip, packaged indi Hersch LASIK irrigating cannula, 23 gauge x 7/8'', spatulated tip, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199545 Catalog Number : 205254

Device Description : Nichamin LASIK irrigating cannula, 25 gauge x 7/8'', vaulted horizontal flattene Nichamin LASIK irrigating cannula, 25 gauge x 7/8'', vaulted horizontal flattened tip, packaged individually, sterile, disposable, box of 10 * * 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 : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199552 Catalog Number : 205256

Device Description : Vidaurri dual extension LASIK irrigating cannula, 25 gauge, angled, two 16 gauge Vidaurri dual extension LASIK irrigating cannula, 25 gauge, angled, two 16 gauge tip extensions, 8 ports, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199569 Catalog Number : 205280

Device Description : Solomon LASIK irrigating cannula, 25 gauge, vaulted, 9.0mm from bend to tip, 6 p Solomon LASIK irrigating cannula, 25 gauge, vaulted, 9.0mm from bend to tip, 6 ports, open spatula tip, packaged individually, sterile, disposable, box of 3 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 10 BOXES AND 4-6 WEEK LEAD TIME * *

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199576 Catalog Number : 211050

Device Description : DALK big bubble cannula, 27 gauge, cuved, 0.40mm single port, blunt tip, package DALK big bubble cannula, 27 gauge, cuved, 0.40mm single port, blunt tip, packaged individually, sterile, disposable, box of 10

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199590 Catalog Number : 585010

Device Description : Lacrimal intubation set, straight tip, 23 gauge x 7'', packaged individually, st Lacrimal intubation set, straight tip, 23 gauge x 7'', packaged individually, sterile, disposable, box of 3

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNL

Prescription Use : Yes

Device Count : 1

Ambler Surgical - 10190660199637 Catalog Number : 585126

Device Description : Lacrimal intubation set, olive tip, 27 gauge x 4 1/4'', packaged individually, s Lacrimal intubation set, olive tip, 27 gauge x 4 1/4'', packaged individually, sterile, disposable, box of 3

Device Class : 1

Duns Number: 015272206

Premarket Exempt : Yes

Product Code : HNL

Prescription Use : Yes

Device Count : 1

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