| Primary Device ID | 00810152821732 |
| NIH Device Record Key | 67c93548-246f-4926-8d14-442ca960a304 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO-ELAST |
| Version Model Number | ELN-3516 |
| Company DUNS | 085719913 |
| Company Name | Ortho Pro Dent LLC |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810152821732 [Primary] |
| ECI | Band, Elastic, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-12 |
| Device Publish Date | 2024-11-04 |
| 00810152820124 | Orthodontic Elastics Non-Latex: Orthodontic elastics Non- Latex 2.5 oz, 1/8" |
| 00810152822135 | Elastomerics Tuff-Ligature Thread 0.030 ” 25 ft / spool Clear |
| 00810152822128 | Elastomerics Tuff-Ligature Thread 0.025” 25 ft / spool Clear |
| 00810152822111 | Elastomerics Tuff-Ligature Thread 0.030” 25 ft / spool Gray |
| 00810152822104 | Elastomerics Tuff-Ligature Thread 0.025” 25ft / spool Gray |
| 00810152822098 | ELASTOMERIC ROTATION WEDGE CLEAR 100/PK |
| 00810152822081 | ELASTOMERIC ROTATION WEDGE GRAY 100/PK |
| 00810152822074 | Elastic Loose Separators 1000/PK |
| 00810152822067 | Latex elastics Extra-Heavy 6.0 oz 3/8" 50 pks of 100 |
| 00810152822050 | Latex elastics Extra-Heavy 6.0 oz 5/16" 50 pks of 100 |
| 00810152822043 | Latex elastics Extra-Heavy 6.0 oz 1/4" 50 pks of 100 |
| 00810152822036 | Latex elastics Extra-Heavy 6.0 oz 3/16" 50 pks of 100 |
| 00810152822029 | Latex elastics Extra-Heavy 6.0 oz 1/8" 50 pks of 100 |
| 00810152822012 | Latex elastics Heavy 4.5 oz 3/8" 50 pks of 100 |
| 00810152822005 | Latex elastics Heavy 4.5 oz 5/16" 50 pks of 100 |
| 00810152821992 | Latex elastics Heavy 4.5 oz 1/4" 50 pks of 100 |
| 00810152821985 | Latex elastics Heavy 4.5 oz 3/16" 50 pks of 100 |
| 00810152821978 | Latex elastics Heavy 4.5 oz 1/8" 50 pks of 100 |
| 00810152821961 | Latex elastics Medium3.5 oz 3/8" 50 pks of 100 |
| 00810152821954 | Latex elastics Medium3.5 oz 5/16" 50 pks of 100 |
| 00810152821947 | Latex elastics Medium3.5 oz 1/4" 50 pks of 100 |
| 00810152821930 | Latex elastics Medium3.5 oz 3/16" 50 pks of 100 |
| 00810152821923 | Latex elastics Medium 3.5 oz 1/8" 50 pks of 100 |
| 00810152821916 | Latex elastics Light 2.5 oz 3/8" 50 pks of 100 |
| 00810152821909 | Latex elastics Light 2.5oz 5/16" 50 pks of 100 |
| 00810152821893 | Latex elastics Light 2.5 oz 1/4" 50 pks of 100 |
| 00810152821886 | Latex elastics Light 2.5 oz 3/16" 50 pks of 100 |
| 00810152821879 | Latex elastics Light 2.5 oz 1/8" 50 pks of 100 |
| 00810152821862 | Non- Latex elastics Extra-Heavy 6.0 oz 3/8" 50 pks of 100 |
| 00810152821855 | Non- Latex elastics Extra-Heavy 6.0 oz 5/16" 50 pks of 100 |
| 00810152821848 | Non- Latex elastics Extra-Heavy 6.0 oz 1/4" 50 pks of 100 |
| 00810152821831 | Non- Latex elastics Extra-Heavy 6.0 oz 3/16" 50 pks of 100 |
| 00810152821824 | Non- Latex elastics Extra-Heavy 6.0 oz 1/8" 50 pks of 100 |
| 00810152821817 | Non- Latex elastics Heavy 4.5 oz 3/8" 50 pks of 100 |
| 00810152821800 | Non- Latex elastics Heavy 4.5 oz 5/16" 50 pks of 100 |
| 00810152821794 | Non- Latex elastics Heavy 4.5 oz 1/4" 50 pks of 100 |
| 00810152821787 | Non- Latex elastics Heavy 4.5 oz 3/16" 50 pks of 100 |
| 00810152821770 | Non- Latex elastics Heavy 4.5 oz 1/8" 50 pks of 100 |
| 00810152821763 | Non- Latex elastics Medium 3.5 oz 3/8" 50 pks of 100 |
| 00810152821756 | Non- Latex elastics Medium 3.5 oz 5/16" 50 pks of 100 |
| 00810152821749 | Non- Latex elastics Medium 3.5 oz 1/4" 50 pks of 100 |
| 00810152821732 | Non- Latex elastics Medium 3.5 oz 3/16" 50 pks of 100 |
| 00810152821725 | Non-Latex elastics Medium 3.5 oz 1/8" 50 pks of 100 |
| 00810152821718 | Non- Latex elastics light 2.5 oz 3/8" 50 pks of 100 |
| 00810152821701 | Non- Latex elastics light 2.5oz 5/16" 50 pks of 100 |
| 00810152821695 | Non- Latex elastics light 2.5 oz 1/4" 50 pks of 100 |
| 00810152821688 | Non- Latex elastics light 2.5 oz 3/16" 50 pks of 100 |
| 00810152821671 | Non- Latex elastics Light 2.5 oz 1/8" 50 pks of 100 |