POLYMER CONCEPTS, INC.

Address:7555 TYLER BLVD STE 1,Mentor,OH,44060,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

Surgical Table Cushion (LWG) (10)

Premarket Exempt

Yes

Clear

XcelGel - 00810048240746 Catalog Number :

Device Description : PC1045L Chest Positioner Left 23/28" x 8" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240753 Catalog Number :

Device Description : PC1045R Chest Positoner R 23/28" x 8" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240760 Catalog Number :

Device Description : PC1045 SET Chest Positioner L & R Set of 2

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240777 Catalog Number :

Device Description : PC1046 Heel Cup 6" x 3-1/4" x 1-3/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240784 Catalog Number :

Device Description : PC1047 Donut Neonatal 3-1/2" x 1-1/2" x 3/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240791 Catalog Number :

Device Description : PC1048 Horseshoe Neonatal 3-1/2" x 1-1/2" x 3/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240807 Catalog Number :

Device Description : PC1049 Duraboard Pad Short 15" x 6" x 3/8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240814 Catalog Number :

Device Description : PC1050 Bariatric Lap Belt Pad Medium 36" x 6" x 1/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240821 Catalog Number :

Device Description : PC1051 Bariatric Lap Belt Pad Large 48" x 7" x 1/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240838 Catalog Number :

Device Description : PC1052 Bariatric Knee Crutch Small 11" x 9" x 1"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

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