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 - 00860008076502 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076519 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076526 Catalog Number :

Device Description : Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407. Color: Blue

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076533 Catalog Number :

Device Description : Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB7 Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407. Color: Blue

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076540 Catalog Number :

Device Description : Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407. Color: Blue

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076557 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076564 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076571 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076588 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Hilo - 00860008076595 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

Device Class : 2

Duns Number: 117057129

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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