Hilo Enterprises LLC

Address:10432 Balls Ford Rd Ste 300,Manassas,VA,20109,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

Gown, Surgical (FYA) (10)

Premarket Exempt

Clear

Hilo - 00850038608002 Catalog Number :

Device Description : Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608019 Catalog Number :

Device Description : Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets re Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608026 Catalog Number :

Device Description : Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608033 Catalog Number :

Device Description : Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608040 Catalog Number :

Device Description : Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608057 Catalog Number :

Device Description : Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE O Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608064 Catalog Number :

Device Description : Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608071 Catalog Number :

Device Description : Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE O Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608088 Catalog Number :

Device Description : Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00850038608095 Catalog Number :

Device Description : Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE US Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue. Case

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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