| Primary Device ID | 08800019140108 |
| NIH Device Record Key | 3bfbcd6d-6688-4327-aebe-281069e6eddf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo R |
| Version Model Number | ENMRMG-R |
| Company DUNS | 687338285 |
| Company Name | B& L Biotech, 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 | 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 | 08800019140108 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
[08800019140108]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
| 08800019140122 | ENMRLG-R |
| 08800019140108 | ENMRMG-R |
| 08800019140085 | ENMRSG-R |