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 - 00810048240210 Catalog Number :

Device Description : PC1004 Foot Section Hip Pad 20" x 20" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240227 Catalog Number :

Device Description : PC1005-B Donut Bariatric 8" x 3" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240234 Catalog Number :

Device Description : PC1005 Donut Adult 8" x 3" x 2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240241 Catalog Number :

Device Description : PC1006 Armboard Large 25" x 5" x 3/8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240258 Catalog Number :

Device Description : PC1007 Armboard X Large 26" x 6" x 3/8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240265 Catalog Number :

Device Description : PC1008 Knee Crutch Large 20" x 20" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240272 Catalog Number :

Device Description : PC1009 Knee Crutch Pad Medium Pediatric Pad 17" x 11" x 1/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240289 Catalog Number :

Device Description : PC1010 SET Lithotomy Boot Pad Set Small Set of 2 with velcro 24" x 11-/1/2" x 6"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240296 Catalog Number :

Device Description : PC1011 SET Lithotomy Boot Pad Large Set of 2 with velcro 27" x 14-1/2" x 8"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240302 Catalog Number :

Device Description : PC1012 Prone and Lateral 15" x 7" x 1/4" bottle shape

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

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