Primary Device ID | 00810048240319 |
NIH Device Record Key | e7f5c15c-103a-447e-9fbf-c03f85491d41 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XcelGel |
Version Model Number | PC1013 |
Company DUNS | 010560097 |
Company Name | POLYMER CONCEPTS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 4409539605 |
cust.serv@polymerconcept.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810048240319 [Primary] |
LWG | Surgical Table Cushion |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-06 |
Device Publish Date | 2020-04-28 |
00810048240012 | 2" Foam Replacment Base |
00810048240005 | 1" Foam Replacement Base |
00810048240050 | Flat Pad Large 18" x 18" x custom height (1/4" - 5/8") |
00810048240043 | Flat Pad Medium 18" x 16" x custom height (1/4"- 5/8") |
00810048240036 | Flat Pad Small 16" x 16" x custom height (1/4" -5/8") |
00810048240029 | 3" Foam Replacement Base |
00810048240296 | PC1011 SET Lithotomy Boot Pad Large Set of 2 with velcro 27" x 14-1/2" x 8" |
00810048240289 | PC1010 SET Lithotomy Boot Pad Set Small Set of 2 with velcro 24" x 11-/1/2" x 6" |
00810048240272 | PC1009 Knee Crutch Pad Medium Pediatric Pad 17" x 11" x 1/4" |
00810048240265 | PC1008 Knee Crutch Large 20" x 20" x 1/2" |
00810048240258 | PC1007 Armboard X Large 26" x 6" x 3/8" |
00810048240241 | PC1006 Armboard Large 25" x 5" x 3/8" |
00810048240234 | PC1005 Donut Adult 8" x 3" x 2" |
00810048240227 | PC1005-B Donut Bariatric 8" x 3" x 3" |
00810048240210 | PC1004 Foot Section Hip Pad 20" x 20" x 1/2" |
00810048240203 | PC1003 Foot Section with cutout 20" x 20" x 1/2" |
00810048240197 | PC1002 Torso Section with cutout 39-1/2" x 20" x 1/2" |
00810048240180 | PC1001 Head Section 20" x 9" x 1/2" |
00810048240173 | PC1000 1 each PC1001, PC1002 and PC1003 |
00810048240166 | PC0833 Chest Roll Pediatric 8" x 3" x 3" |
00810048240159 | PC0822 Chest Roll Pediatric 8" x 2" x 2" |
00810048240142 | PC0633 Chest Roll Pediatric 6" x 3" x 3" |
00810048240135 | PC0622 Chest Roll Pediatric |
00810048240128 | PC0448 Bariatric Lap Belt Pad Small 48" x 4" x 1/4" |
00810048240111 | PC0433 Chest Roll Pediatric 4" x 3" x 3" |
00810048240104 | PC0422 Chest Roll Pediatric 4" x 2" x 2" |
00810048240081 | PC0022 Chest Roll Pediatric 10" x 2" x 2" |
00810048240074 | PCMINI Sample Mini Pad 5" x 4" x 3/8" |
00810048240067 | Flat Pad X Large 20" x 20" x custom height (1/4" - 5/8") |
00810048240340 | PC1015-24 Full Table Pad Large 72" x 24" x 1/2" |
00810048240333 | PC1015 Full Table Pad 72" x 20" x 1/2" |
00810048240326 | PC1014 3/4 Table Pad with cutout 46" x 20" x 1/2" |
00810048240319 | PC1013 3/4 Table Pad no Cutout 46" x 20" x 1/2" |
00810048240302 | PC1012 Prone and Lateral 15" x 7" x 1/4" bottle shape |
00810048240395 | PC1018 Donut Pediatric 5-1/2" x 2-1/4" x 1-1/4" |
00810048240388 | PC1017 Armboard Small 15" x 4" x 1/4" |
00810048240371 | PC1016-4C Horseshoe Adult Case of 4 8" x 3" x 2" each |
00810048240364 | PC1016-B Horseshoe Bariatric 8" x 3" x 3" |
00810048240357 | PC1016 Horseshoe Adult 8" x 3" x 2" |
00810048240579 | PC1032 Chest Roll Flat Bottom16" x 4" x 4" |
00810048240562 | PC1031 Chest Roll Flat Bottom 12" x 6" x 6" |
00810048240555 | PC1030 Chest Roll Flat Bottom 12" x 4" x 4" |
00810048240548 | PC1029 SANDBAG LARGE 14" x 5" x 2" |
00810048240531 | PC1029-0 SANDBAG XTRA LARGE 18" x 6" x 2" |
00810048240722 | PC1043 Set 29" x 10' x 1/2" Wilson Frame Pad Set |
00810048240715 | PC1043 Wilson Frame Pad 29" x 10" x 1/2" |
00810048240708 | PC1042 10" x 9" x 1" Lateral Head Pad with Center Dish |
00810048240692 | PC1041 Layer Pad 16" x 8" x 1/2" |
00810048240661 | PC1040GP Arm Leg Tobogga Pad Straight 17" x 8" x 3/8" |
00810048240791 | PC1048 Horseshoe Neonatal 3-1/2" x 1-1/2" x 3/4" |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XCELGEL 85578104 4233754 Live/Registered |
Polymer Concepts, Inc. 2012-03-23 |