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) (5) Wrap, sterilization (FRG) (3) GOWN, SURGICAL (FYA) (2)

Premarket Exempt

No Yes

Clear

Encompass - 00609953086644 Catalog Number :

Device Description : SHEET,DRAPE 40X60 WHITE HEM TH

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953097015 Catalog Number :

Device Description : 2 PLY WRAPPER 45X45 HEM JADE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Encompass - 00609953183800 Catalog Number :

Device Description : UNIV. EYE/CIRC. 2" SAFE/C

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953184029 Catalog Number :

Device Description : UNIV. EYE/CIRC. 3" SAFE/C

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953184135 Catalog Number :

Device Description : EYE DRAPE T140 MIST

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953190327 Catalog Number :

Device Description : 2 PLY WRAPPER 54X54 HEM JADE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Encompass - 00609953197814 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 - 00609953198415 Catalog Number :

Device Description : T180-SHEET JADE 70X90 1 PLY

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRG

Prescription Use : No

Device Count : 1

Encompass - 00609953198439 Catalog Number :

Device Description : SHEET EYE 28X23 JADE

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Encompass - 00609953213484 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

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