| Primary Device ID | 00850038184100 |
| NIH Device Record Key | 6ea31533-de59-4b5c-abbc-f2e82a022a29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho Traction Pads |
| Version Model Number | MPEP XL |
| Company DUNS | 013718230 |
| Company Name | ORTHOTRACTION PADS,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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850038184100 [Primary] |
| EJF | Bracket, Metal, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
[00850038184100]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2021-12-13 |
| 00850038184186 | Nikodem Plain Spring 18mm - PS-18 |
| 00850038184162 | Nikodem Spring On Pad 9mm - SOP-9 |
| 00850038184155 | MPEP 2 Inch Chain - MPEP 2 Inch Chain |
| 00850038184148 | MPEP Larger Pad - MPEP Larger |
| 00850038184131 | Small Pad Eyelet Profile XL Chain - SPEP XL |
| 00850038184124 | Round Pad Eyelet Profile XL Chain - RPEP XL |
| 00850038184117 | Mesh Pad Low Profile XL Chain - MPLP XL |
| 00850038184100 | Mesh Pad Eyelet Profile XL Chain - MPEP XL |
| 00850038184094 | Large Pad Low Profile XL Chain - LPLP XL |
| 00850038184087 | Button Pad Round XL Chain - BPRO XL |
| 00850038184070 | Button Pad Oval Curved XL Chain - BPOC XL |
| 00850038184063 | Small Pad Eyelet Profile - SPEP |
| 00850038184056 | Round Pad Eyelet Profile - RPEP |
| 00850038184049 | Mesh Pad Low Profile - MPLP |
| 00850038184032 | Mesh Pad Eyelet Profile - MPEP |
| 00850038184025 | Large Pad Low Profile - LPLP |
| 00850038184018 | Button Pad Round - BPRO |
| 00850038184001 | Button Pad Oval Curved - BPOC |