Encompass Group, L.L.C.

Address:615 MACON RD.,Mc Donough,GA,30253,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

Drape, surgical (KKX) (6) Wrap, sterilization (FRG) (3) GOWN, SURGICAL (FYA) (1)

Premarket Exempt

No Yes

Clear

Encompass - 00609953600925 Catalog Number :

Device Description : SAFECARE STANDARD GOWN

Device Class : 2

Duns Number: 121788819

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Encompass - 00609953600932 Catalog Number :

Device Description : 1 PLY WRAPPER 12X12 SERGE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Encompass - 00609953608907 Catalog Number :

Device Description : SMALL FENESTRATED DRAPE 12X12

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953612362 Catalog Number :

Device Description : 1 PLY WRAPPER 18X18 SERGE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Encompass - 00609953614434 Catalog Number :

Device Description : SMALL FENESTRATED DRAPE 22X22

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953614458 Catalog Number :

Device Description : SMALL FENESTRATED DRAPE 16X23

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953614496 Catalog Number :

Device Description : 32X32 DRESSING SHEET 9X9-4 WIT

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953722696 Catalog Number :

Device Description : DRAPE VASECTOMY 2 PLY

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953724379 Catalog Number :

Device Description : DRAPE EYE 30X30 W/4" FEN

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953727851 Catalog Number :

Device Description : 1 PLY WRAPPER 24X24 SERGE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

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