| Primary Device ID | 00840456215227 |
| NIH Device Record Key | f9f39527-03ce-46f4-8fa4-dde73a91d5de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Generic Packing (No Brand) |
| Version Model Number | 36101003 |
| Company DUNS | 081258380 |
| Company Name | JMU DENTAL, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00840456215227 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
[00840456215227]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 00840456215234 | Dental Tofflemire Matrix Bands, #2, Stainless Steel, Thickness .0015"/0.04mm,144pcs/bag |
| 00840456215227 | Dental Tofflemire Matrix Bands, #1, Stainless Steel, Thickness .0015"/0.04mm,144pcs/bag |