Dukal LLC

Dukal LLC

Address:2 Fleetwood Ct.,Ronkonkoma,NY,11779,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

FIBER, MEDICAL, ABSORBENT (FRL) (8) Drape, surgical (KKX) (1) Tracheostomy and nasal suctioning kit (LRQ) (1)

Premarket Exempt

No Yes

Clear

Dukal - 00665973000374 Catalog Number : CT-01B

Device Description : OR Towel Sterile

Device Class : 1

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 1

Dukal - 00665973000404 Catalog Number : CT-02B

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"Blue

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 2

Dukal - 00665973000428 Catalog Number : CT-02G

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"Green

Device Class :

Duns Number: 791014871

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 2

Dukal - 00665973000435 Catalog Number : CT-04B

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"Blue

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 4

Dukal - 00665973000442 Catalog Number : CT-04W

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"White

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 4

Dukal - 00665973000459 Catalog Number : CT-04G

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"Green

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 4

Dukal - 00665973000466 Catalog Number : CT-06B

Device Description : DK OR Towel,CSR Wrap,Softpack,ST 16"x26",Blue

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 6

Dukal - 00665973000497 Catalog Number : CT-08B

Device Description : DK OR Towel,CSR Wrap,Softpack,ST 16"x26",Blue

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 8

Dukal - 00665973000527 Catalog Number : CT-12B

Device Description : DK OR TowelCSR WrapSoftpack,ST16"x26"Blue

Device Class :

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 12

Dukal - 00665973006437 Catalog Number : 15200

Device Description : DK Trach Care Kit, ST

Device Class : 1

Duns Number: 791014871

Premarket Exempt : Yes

Product Code : LRQ

Prescription Use : No

Device Count : 1

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