HAMMER-PLANE INC

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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

Support, Breathing Tube (JAY) (3)

Premarket Exempt

Yes

Clear

Stronghold - 00860002529004 Catalog Number : SSDD

Device Description : Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes

Device Class :

Duns Number: 791765001

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

Stronghold - 00860002529011 Catalog Number : ADD

Device Description : Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch neck flange

Device Class : 1

Duns Number: 791765001

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

Stronghold - 00860002529028 Catalog Number : PDD

Device Description : Stronghold anti-disconnect device for neonate/pediatric tracheostomy tubes

Device Class : 1

Duns Number: 791765001

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

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