Primary Device ID | 00190746031526 |
NIH Device Record Key | ce051059-56f1-45f9-880b-e04d890974b2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Wildlife |
Version Model Number | 000-134 |
Catalog Number | 000-134 |
Company DUNS | 044668515 |
Company Name | AMERICAN ORTHODONTICS CORPORATION |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com | |
Phone | +1(800)558-7687 |
info@americanortho.com |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Light |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190746031526 [Primary] |
ECI | BAND, ELASTIC, ORTHODONTIC |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-07 |
Device Publish Date | 2019-05-16 |
00190746031663 | ELASTICS INTRA-ORAL HEAVY 6.5 OZ 3/8" 1000/BAG |
00190746031656 | ELASTICS INTRA-ORAL HEAVY 6.5 OZ 5/16" 1000/BAG |
00190746031649 | ELASTICS INTRA-ORAL HEAVY 6.5 OZ 1/4" 1000/BAG |
00190746031632 | ELASTICS INTRA-ORAL HEAVY 6.5 OZ 3/16" 1000/BAG |
00190746031625 | ELASTICS INTRA-ORAL HEAVY 6.5 OZ 1/8" 1000/BAG |
00190746031618 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 3/4" 1000/BAG |
00190746031601 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 5/8" 1000/BAG |
00190746031595 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 3/8" 1000/BAG |
00190746031588 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 5/16" 1000/BAG |
00190746031571 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 1/4" 1000/BAG |
00190746031564 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 3/16" 1000/BAG |
00190746031557 | ELASTICS INTRA-ORAL MEDIUM 4.5 OZ 1/8" 1000/BAG |
00190746031540 | ELASTICS INTRA-ORAL LIGHT 2.5 OZ 3/4" 1000/BAG |
00190746031533 | ELASTICS INTRA-ORAL LIGHT 2.5 OZ 5/8" 1000/BAG |
00190746031526 | ELASTICS WILDLIFE PUMA EXTRA HEAVY 8 OZ 3/8" 2 BOXES 50/BOX |
00190746031519 | ELASTICS WILDLIFE LEOPARD EXTRA HEAVY 8 OZ 5/16" 2 BOXES 50/BOX |
00190746031502 | ELASTICS WILDLIFE JAGUAR EXTRA HEAVY 8 OZ 1/4" 2 BOXES 50/BOX |
00190746031496 | ELASTICS WILDLIFE CHEETAH EXTRA HEAVY 8 OZ 3/16" 2 BOXES 50/BOX |
00190746031489 | ELASTICS WILDLIFE RHINOCEROS HEAVY 6.5 OZ 3/8" 50/BOX |
00190746031472 | ELASTICS WILDLIFE RHINOCEROS HEAVY 6.5 OZ 3/8" 2 BOXES 50/BOX |
00190746031465 | ELASTICS WILDLIFE MANATEE HEAVY 6.5 OZ 5/16" 50/BOX |
00190746031458 | ELASTICS WILDLIFE MANATEE ASSORT NEON HEAVY 6.5 OZ 5/16" 75/BOX |
00190746031441 | ELASTICS WILDLIFE MANATEE HEAVY 6.5 OZ 5/16" 2 BOXES 50/BOX |
00190746031434 | ELASTICS WILDLIFE SEA LION HEAVY 6.5 OZ 1/4" 50/BOX |
00190746031427 | ELASTICS WILDLIFE SEA LION ASSORT NEON HEAVY 6.5 OZ 1/4" 75/BOX |
00190746031410 | ELASTICS WILDLIFE SEA LION HEAVY 6.5 OZ 1/4" 100/BOX |
00190746031403 | ELASTICS WILDLIFE TORTOISE HEAVY 6.5 OZ 3/16" 50/BOX |
00190746031397 | ELASTICS WILDLIFE TORTOISE ASSORT NEON HEAVY 6.5 OZ 3/16" 75/BOX |
00190746031380 | ELASTICS WILDLIFE TORTOISE HEAVY 6.5 OZ 3/16" 100/BOX |
00190746031373 | ELASTICS WILDLIFE ELEPHANT HEAVY 6.5 OZ 1/8" 50/BOX |
00190746031366 | ELASTICS WILDLIFE ELEPHANT ASSORT NEON HEAVY 6.5 OZ 1/8" 75/BOX |
00190746031359 | ELASTICS WILDLIFE ELEPHANT HEAVY 6.5 OZ 1/8" 100/BOX |
00190746031342 | ELASTICS WILDLIFE TIGER MEDIUM 4.5 OZ 3/8" 50/BOX |
00190746031335 | ELASTICS WILDLIFE TIGER MEDIUM 4.5 OZ 3/8" 2 BOXES 50/BOX |
00190746031328 | ELASTICS WILDLIFE PANDA MEDIUM 4.5 OZ 5/16" 50/BOX |
00190746031311 | ELASTICS WILDLIFE PANDA ASSORT NEON MEDIUM 4.5 OZ 5/16" 75/BOX |
00190746031304 | ELASTICS WILDLIFE PANDA MEDIUM 4.5 OZ 5/16" 100/BOX |
00190746031298 | ELASTICS WILDLIFE EAGLE MEDIUM 4.5 OZ 1/4" 50/BOX |
00190746031281 | ELASTICS WILDLIFE EAGLE ASSORT NEON MEDIUM 4.5 OZ 1/4" 75/BOX |
00190746031274 | ELASTICS WILDLIFE EAGLE MEDIUM 4.5 OZ 1/4" 100/BOX |
00190746031267 | ELASTICS WILDLIFE GORILLA MEDIUM 4.5 OZ 3/16" 50/BOX |
00190746031250 | ELASTICS WILDLIFE GORILLA ASSORT NEON MEDIUM 4.5 OZ 3/16" 75/BOX |
00190746031243 | ELASTICS WILDLIFE GORILLA MEDIUM 4.5 OZ 3/16" 100/BOX |
00190746031236 | ELASTICS WILDLIFE WOLF MEDIUM 4.5 OZ 1/8" 50/BOX |
00190746031229 | ELASTICS WILDLIFE WOLF ASSORT NEON MEDIUM 4.5 OZ 1/8" 75/BOX |
00190746031212 | ELASTICS WILDLIFE WOLF MEDIUM 4.5 OZ 1/8" 100/BOX |
00190746031205 | ELASTICS WILDLIFE HAWK LIGHT 2.5 OZ 3/4" 5000/BOX |
00190746031199 | ELASTICS WILDLIFE EGRET LIGHT 2.5 OZ 5/8" 5000/BOX |
00190746031182 | ELASTICS WILDLIFE HYENA LIGHT 2.5 OZ 3/8" 50/BOX |
00190746031175 | ELASTICS WILDLIFE HYENA LIGHT 2.5 OZ 3/8" 100/BOX |