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 - 00810048240111 Catalog Number :

Device Description : PC0433 Chest Roll Pediatric 4" x 3" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240128 Catalog Number :

Device Description : PC0448 Bariatric Lap Belt Pad Small 48" x 4" x 1/4"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240135 Catalog Number :

Device Description : PC0622 Chest Roll Pediatric

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240142 Catalog Number :

Device Description : PC0633 Chest Roll Pediatric 6" x 3" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240159 Catalog Number :

Device Description : PC0822 Chest Roll Pediatric 8" x 2" x 2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240166 Catalog Number :

Device Description : PC0833 Chest Roll Pediatric 8" x 3" x 3"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240173 Catalog Number :

Device Description : PC1000 1 each PC1001, PC1002 and PC1003

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240180 Catalog Number :

Device Description : PC1001 Head Section 20" x 9" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240197 Catalog Number :

Device Description : PC1002 Torso Section with cutout 39-1/2" x 20" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

XcelGel - 00810048240203 Catalog Number :

Device Description : PC1003 Foot Section with cutout 20" x 20" x 1/2"

Device Class : 1

Duns Number: 010560097

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

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