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 - 00810048240647 Catalog Number :

Device Description : PC1038 Knee Crutch X Large 27" x 11" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240654 Catalog Number :

Device Description : PC1039 Sandbag 16" x 12" x 1-1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240661 Catalog Number :

Device Description : PC1040GP Arm Leg Tobogga Pad Straight 17" x 8" x 3/8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240678 Catalog Number :

Device Description : PC1040SD Arm Leg Toboggan Shield Straight 15-3/4" x 9-1/2" x 3/8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240685 Catalog Number :

Device Description : PC1040 Set 1 Pad and 1 Shield

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240692 Catalog Number :

Device Description : PC1041 Layer Pad 16" x 8" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240708 Catalog Number :

Device Description : PC1042 10" x 9" x 1" Lateral Head Pad with Center Dish

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240715 Catalog Number :

Device Description : PC1043 Wilson Frame Pad 29" x 10" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240722 Catalog Number :

Device Description : PC1043 Set 29" x 10' x 1/2" Wilson Frame Pad Set

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240739 Catalog Number :

Device Description : PC1044 Supine Head Pad with Center Dish Adult 10" x 9-1/2" x 1-1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

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